Nicola Rossi, Director of Communications, BT Health, has been appointed Director of Communications for the National Pharmacy Association. Nicola will be taking up her new role in December 2009.

Nicola has spent the last three years managing communications for BTs NHS contracts and in that time she has worked with her team to build a comprehensive proactive communications programme as well as ensuring that external interest in BTs work in health is handled professionally. Immediately prior to that, she set up BTs first analyst relations programme, independently benchmarked as one of the best in the Europe. She has been working in communications management roles for BT for more than 20 years.

Nicola said “Community pharmacy is extremely popular with the general public. With its ubiquitous membership the NPA has a legitimate voice on a whole range of healthcare issues. My job will be to ensure that voice is heard, on behalf of community pharmacy, helping it to play a strategic role in policy making and service delivery.”

John Turk, Chief Executive of the National Pharmacy Association said “We have made this appointment to strengthen our representation with our most influential stakeholders. I am delighted that Nicola is joining us. She has a very strong track record working with strategic audiences and I look forward to working with her.”

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APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., (NASDAQAPCVZ) announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to market Deferoxamine Mesylate for Injection, USP, in two dosage strengths. Deferoxamine Mesylate is therapeutically equivalent to the referencelisted drug Desferal®, which is marketed by the innovator Novartis.

APP will package Deferoxamine Mesylate in single dose vials of 500 mg, 10 mL and 2 gram, 30 mL. APPs Deferoxamine Mesylate is APrated, barcoded and latexfree. According to IMS data, 2008 sales of this product in the United States were approximately $11.8 million1.

Deferoxamine Mesylate is an iron chelating agent that is used for iron poisoning as well as chronic iron overload due to transfusiondependent anemias. In the case of acute iron poisoning, Deferoxamine Mesylate is most effective when given early in the treatment of iron poisoning. Longterm treatment with Deferoxamine Mesylate has been shown to slow the accumulation of excess iron in the liver and can slow or eliminate the progression of a serious form of liver damage called liver fibrosis.

APP plans to launch Deferoxamine Mesylate in the fourth quarter of 2009, which will further expand the companys critical care product line.

About APP Pharmaceuticals, Inc.

APP Pharmaceuticals, Inc. is a fullyintegrated pharmaceutical company that develops, manufactures and markets injectable pharmaceutical products with a primary focus on the oncology, antiinfective, anesthetic/analgesic and critical care markets. The company offers one of the most comprehensive product portfolios used in hospitals, longterm care facilities, alternate care sites and clinics within North America and manufactures a comprehensive range of dosage formulations. Fresenius Kabi Pharmaceuticals Holding, Inc., a wholly owned subsidiary of Fresenius Kabi AG, acquired APP Pharmaceuticals, Inc. on September 10, 2008. For more information about APP Pharmaceuticals, Inc., please visit the companys Web site at APPpharma.com.

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The National Association of Chain Drug Store (NACDS) implemented its Rapid Response Program, following a recent editorial on drug importation.NACDS President and CEO Steven C. Anderson, IOM, CAE penned a response to the editor to the Delaware County Daily Times (Delaware County, Pa.) after an editorial ran on August 19 citing NACDS and asserting that chain drug stores should not be concerned about where prescription medications come from so long as they are less expensive for consumers to purchase. Here is a link to the editorial

The NACDS Rapid Response Program was created to address inaccurate or inappropriate portrayals of pharmacy, or call attention to an issue that impacts the pharmacy industry. Below is the text of Andersons response

Dear Editor

The August 19 editorial, “Yelling and partisanship wont solve crisis”, inaccurately asserts that chain drug stores should not worry about the origin of prescription drugs so long as they are inexpensive for consumers.

Pharmacies are convenient, accessible healthcare providers. Your neighborhood pharmacist counsels patients in obtaining the most cost effective and appropriate medications and therapies to improve their health outcomes.

However, we do not believe that consumer safety should be compromised to achieve lower costs. Safety cannot be ensured in any system that allows for the personal importation of prescription medications. In addition, individuals who obtain prescription medications through a personal importation scheme do not have a licensed pharmacist available to consult with them about using the medications safely and effectively.We are committed to advancing policies that expand consumer access to safe, affordable, and effective prescription drugs, which is a key component of a reformed system.

Steven C. Anderson, IOM, CAE
President and CEO

Outcome Sciences, Inc. (OUTCOME), the leading provider of patient registries, studies, and technologies for evaluating realworld outcomes, announced that Nancy Dreyer, MPH, PhD, Chief of Scientific Affairs and Senior Vice President at Outcome, will be presenting at the International Society for Pharmacoepidemiologys (ISPE) 25th Anniversary International Conference on Pharmacoepidemiology and Therapeutic Risk Management. The conference is being held from August 1619 at the Rhode Island Convention Center in Providence, Rhode Island.

The first session, entitled “Can Registries Deliver? The Methods and Use of Registries for Biologics”, will be held on Monday, August 17th at 330 P.M. and will focus on the unusual challenges in studying the safety and effectiveness of biologics, and how registries are being used to generate evidence. Panelists will discuss design issues, considerations for interpreting data from biologics registries, and the regulatory perspective on risk management.

On Tuesday, August 18th at 245 P.M., Dr. Dreyer will participate in the case study discussion “Human Avian Influenza Development of a ShoeLeather Approach to Evaluating Treatment Effectiveness.” This successful case study highlights a global initiative to study clinical presentation, natural history, treatment effectiveness and clinical outcomes for human avian influenza. The participants will present an oldfashioned approach to building collaboration, country by country, along with the studys learned lessons and potential applicability to other pandemic threats.

Dr. Dreyers final presentation, “Developing Good Practice Guidance for NonRandomized Studies of Comparativeness Effectiveness A Workshop on Quality and Transparency”, will take place at 400 P.M. on Tuesday, August 18th. This workshop will address the study of comparative effectiveness using observational studies. Panelists will present an overview of comparative effectiveness, describe ongoing guidance activities from a U.S. government perspective, and present the GRACE Principles for review and discussion. The GRACE principles are the product of a broad initiative intended to provide highlevel guidance to reviewers seeking to evaluate observational studies of comparative effectiveness and distinguish highquality work. Learn more about the GRACE principles at graceprinciples.org.

For additional information on 25th Anniversary International Conference of Pharmacoepidemiology and Therapeutic Risk Management taking place on August 1619, 2009, please go to spharmacoepi.org/meetings/25thconf/index.cfm. Outcome is also exhibiting at the conference and is located at booth #1.

About the International Society for Pharmacoepidemiology (ISPE)

ISPE is an international organization dedicated to advancing the health of the public by providing a forum for the open exchange of scientific information and for the development of policy; education; and advocacy for the field of pharmacoepidemiology, including pharmacovigilance, drug utilization research, and therapeutic risk management.

Additional information on ISPE can be found on the ISPE website at spharmacoepi.org/

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“Gov. Arnold Schwarzenegger [of California] on Wednesday conceded that longstanding delays in disciplining errant health professionals were absolutely unacceptable and promised broad reforms to better protect patients from dentists, pharmacists, therapists and others accused of misconduct,” ProPublica/The Los Angeles Times reports. The reforms will include adding more investigators and auditors and new laws to fasttrack suspensions of licenses of professionals who dont comply with rules. The reforms would be subsidized by hiking licensing fees, and come a month after an investigation by the two news organizations revealed that it took an average of three years to conclude investigations of nurses accused of wrongdoing.

Schwarzenegger hopes to cut that time in half with the reforms that would target all 18 “healing arts” boards that regulate the states 900,000 health workers. He took earlier action to replace members of the states nursing board. “Despite the dramatic gestures, Schwarzeneggers own actions may have contributed to problems” at the boards, ProPublica/The Los Angeles Times reports. “A blizzard of budgetcutting,” work furloughs, and failure to promptly fill vacancies on healthrelated boards may be contributing to the problems (Weber, Ornstein and Lin, 8/13).

This information was reprinted from kaiserhealthnews.org with kind permission from the Henry J. Kaiser Family Foundation. You can view the entire Kaiser Daily Health Policy Report, search the archives and sign up for email delivery at kaiserhealthnews.org.

© Henry J. Kaiser Family Foundation. All rights reserved.

Some seniors in Illinois are delaying buying prescription drugs because of the cost, according to the AARP. United Press International reports “Twentyone percent of AARP members surveyed in Illinois report not filling or delaying filling prescriptions due to cost, a survey indicated. Nearly one in five said they had to cut back on food and utilities to afford needed medications, the AARP survey of Illinois residents 50 and over indicated. The survey found 63 percent are concerned about affordability of their prescription drugs. Eighteen percent reported they took less than the prescribed amount to make the medicine last longer. The survey found women and Hispanics say they tend to be harder hit than the general 50plus population by high drug costs. In the past year, prices for brandname prescription drugs increased an average of 8.7 percent, while generic drug prices decreased by nearly 11 percent, Merri Dee, president for AARP in Illinois, said. Prices of specialty prescription drugs, used to treat conditions that tend to affect older populations such as cancer and rheumatoid arthritis, increased by 9.3 percent” (7/13).

This information was reprinted from kaiserhealthnews.org with kind permission from the Henry J. Kaiser Family Foundation. You can view the entire Kaiser Daily Health Policy Report, search the archives and sign up for email delivery at kaiserhealthnews.org.

© Henry J. Kaiser Family Foundation. All rights reserved.

Mylan Inc.s (NASDAQ MYL) Chief Operating Officer Heather Bresch today testified before the U.S. House of Representatives Judiciary Subcommittee on Courts and Competition Policy concerning patent litigation settlements between branded pharmaceutical companies and generic pharmaceutical companies. During her testimony, Bresch conveyed Mylans position that the launch of an authorized generic by brand companies during a generic companys 180day exclusivity period undermines competition and delays timely access to high quality, affordable generic medications for patients, taxpayers, the government and businesses.

The committees hearing, “Pay to Delay Are Patent Settlements That Delay Generic Drug Market Entry Anticompetitive?,” was called to gather information about the effects of settlements.

Bresch commented “When it comes to settlements, Congress need look no further than the use and abuse of authorized generics by brand manufacturers. The increase in the number of patent litigation settlements in recent years is directly related to the increased use of authorized generics during the 180day market exclusivity period. This tactic upsets the natural balance of incentives that Congress intended with its 1984 HatchWaxman legislation.”

Bresch continued “Congress has an opportunity to act now to ensure that timely access to affordable generics is offered to patients by restoring the true 180day exclusivity period. This is even more profound and critical today as Congress deliberates on a regulatory pathway for lifesaving generic biologics, treatments that can cost hundreds of thousands of dollars per patient per year.”

A complete version of Breschs written testimony for the subcommittee hearing can be found here.

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The Wall Street Journal on Tuesday examined how “consumers are receiving a flood of safety lore about the drugs they take so lots that it risks scaring some society.” According to the Journal, a recent “series of prescription medication scares” has prompted the media, consumer advocacy bunchs and FDA to release more earful regarding the safety of prescription medications. However, the proliferation of such inside news item “might overwhelm patients and raise undue alarm,” according to some medical professionals. The Journal warns that patients “may forget about the benefits of a medication if they fix only on risk,” and “the euphoria consequences associated with stopping a medication … may be far worse than the possibility of a side effect.”

According to a Pfizer survey conducted in March of 300 medical professionals, 89% of respondents said they were at least somewhat concerned that patients would stop taking medications if potentially negative safety report was released too early. In accession, a 2008 study by the Kaiser house Foundation, Harvard School of Public tone and USA Today constitute that 27% of U.S. residents feel “very confident” in the safety of prescription drugs sold in the U.S. and a little more than half feel that drug companies do comfortable to evaluation and monitor drug safety. However, drug industry officials say the skepticism regarding drug safety might only be temporary, the Journal reports.

Drug industry experts say that one abeyant problem is that manifold patients take “safe” to mean virtually no risk, Timothy Lesar, director of Clinical Pharmacy Services at Albany Medical Center and a member of FDAs drug safety advisory committee, said. He said, “There are no guarantees and there are always risks,” adding, “If were going to take risk, we hunger to cook up indisputable there are benefits here.”

Efforts at Clarity
Pharmaceutical companies such as Pfizer, Wyeth and Johnson & Johnson are “ramping up efforts to be more open about drug safety,” and FDA as well is “taking steps to stay alerting consumers about drugsafety issues while essaying not to cause unnecessary perplexity,” the Journal reports. According to FDA drug safety OKd Paul Seligman, FDA intends to chicken cater its early notification letters about drugsafety concerns to tabulation the statistic of adverse events that have occurred compared with the harbinger of public taking the drug and post such concerns on WebMD.

Seligman said that the effects of providing more safety clue are not yet clear, adding that FDA plans to study consumers reactions and use of safety tidings. He said, “Were always aware and fancy to strive to whip out genuine that that (safety) notification is provided in a way that outweighs any unintended consequences” (Wang, Wall Street Journal, 12/9).

Reprinted with kind permission from kaisernetwork.org. You can view the entire Kaiser Daily healthiness channels Report, search the archives, or signal up for subscription delivery at kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily wholeness protocol Report is published for kaisernetwork.org, a free use of The Henry J. Kaiser generations Foundation.

&pattern; 2008 Advisory Board pack and Kaiser brood Foundation. All rights cool.

Clinicians using an electronic prescribing red tape appear more prone to prescribe lowercost medications, reducing drug spending, according to a report in the December 8/22 issue of Archives of Internal Medicine, one of the JAMA/Archives journals.

“Prescription drug costs chronicle for a significant proportion of medical spending and have fossilized expanding rapidly,” the authors write as background erudition in the blurb. One method for encouraging use of lowercost medications is a tiered copayment combination. Insurers identify preferred medications, such as generic drugs, and designate them “tier 1″ with the lowest copayment. Moderately priced qualityprenomen medications may be designated repeatedtier and assigned a higher copayment, and thirdtier drugs represent expensive charactermonogram medications for which generic alternatives are available and have the highest copayment.

“A key limitation of tiered copayment systems is prescribers inability to keep track of differing copayment tiers opposite insurance plans formularies,” the authors write. Michael A. Fischer, M.D., M.S., of Brigham and Womens Hospital and Harvard Medical School, Boston, studied an electronic prescribing (eprescribing) organization designed to address that issue. In April 2004, two considerable Massachusetts insurers began using the coordination, which provided communitybased practices with free wireless devices and access to a secure web portal that colorcoded drugs by copayment tier. Using 18 months of measurements, the researchers compared the quarters in proportion of prescriptions for the three tiers before and after eprescribing began, and and compared the prescription habits of clinicians using the eprescribing rule to those of controls.

in October 2003 and March 2005, more than 1.5 million patients filled 17.4 million prescriptions. After implementation of eprescribing, tier 1 prescriptions increased by 3.3 percent and another and thirdtier prescriptions decreased accordingly among clinicians using the scheme. Eprescriptions of tier 1 medications increased 6.6 percent, compared with a 2.6 percent development among prescriptions from the inside track group.

Among clinicians using the new structure, eprescriptions accounted for 20 percent of prescriptions. These clinicians prescribed more tier1 medications than the qualification group even when not eprescribing; however, prescriptions of lowercost medications were best common among eprescriptions.

Based on average medication costs for private insurers, the researchers estimate that using such an eprescribing orderliness at that rate could creature in savings of $0.70 per patient per month, or $845,000 annually per 100,000 insured patients filling prescriptions. “The unrealized savings enlargement with more availability and use of eprescribing; for complete eprescribing use, the projected savings are $3.91 million per 100,000 patients per year,” the authors write.

“Our results suggest that there are of substance economic gains achievable through the broader use of eprescribing with formulary decision support but that merely providing eprescribing systems to clinicians will not necessarily achieve those savings,” they conclude. “Rather, prescribers be Needy to adopt the eprescribing systems fully for these gains to be realized. Making those changes represents an necessary goal for physicians, insurers and all those with a stake in the cost of prescription medications.” (Arch Intern Med. 2008;168[22]24332439.)

Editors Note that study was supported by a grant from the Agency for Healthcare Research and Quality and a career development grant from the National Institutes of wholeness. Please see the column for additional illumination, including other authors, reporter contributions and affiliations, financial disclosures, funding and support, etc.

The NPA has met acclimatized 1000 portions at NPA events that year. The programme of regional meetings have focussed on providing work and practice advice and support, as well as giving an opportunity for dialogue mid the NPA and our associates on a range of issues.

Regional events have taken quarter in a variety of locations including Aberdeen, Belfast, Birmingham, Edinburgh, Glasgow, London and Manchester.

John Turk, NPA Chief Executive said

“Im delighted so multiplied components have taken up the opportunity to meet the NPA team that year. We feeler units a vast array of services, and these events are a super way of letting them perceive equitable what is available from the NPA. Of equal importance is the moment we have spent listening to what branchs yen from the Association. We have heard loud and clear what our sections near, what they hunger more of, as well as the qualities we could do differently. We will be putting that learning into practice while 2009 and beyond.”

A full programme of NPA member events for 2009 will be published on the NPA website in the coming weeks. For further dirt please contact NPA demanding negotiating@npa.co.uk.

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Mark Beckett