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August 2008 Archives

August 2, 2008

The Niche blog by Nature.com

Since June 2007, Nature Reports Stem Cells has hosted a blog, 'The Niche" to provide an informal forum for debate and commentary on stem cell research and its wider implications for ethics, policy, business, and medicine.
This blog is a great place to check up on perspectives about what is happening in the fast paced stem cell world, globally--the webpage itself is well organized so even a quick visit yields a good sense of what is going on.
A new educational feature there as reported 7/31/08 by Monya Baker, is 'Movies on Nature Reports Stem Cells'-- free multimedia presentations on stem cells (on the Nature.com website). She indicates that this feature should be live in the next few days.
Stanford's Christopher Scott, Harvard's Willy Lensch, and University of Southern California's Martin Pera provided their thoughtful comments and suggestions on Nature's stem cell FAQs section.

Stem cells have a great but still uncertain medical potential. They offer scientific insights into how cells develop and how some diseases might be treated. Here we define them, describe how they are studied, and sketch their potential and the controversies that surround them.

Areas of focus include:
Physiology
In the laboratory
Medicine
Ethics and policy
(1) http://blogs.nature.com/reports/theniche/

In the spotlight: FDA key initiatives

Today's FDA webpage show key initatives in their 'Spotlight' focus. This provides a nice overview of what is happening here in recent history and links to the respective website that focuses on each initiative.

Through specially targeted initiatives, FDA intensifies efforts to ensure the safety of America’s food supply, and to make safe, effective, and affordable medical products available to the public, whether imported or made in the USA.

Read below the fold for their capsule of info for each initiative.
1. FDA's Sentinel Initiative
2. Action Plan for Import Safety
3.Food Protection Plan
4. China Partnerships
5.Generic Initiative for Value and Efficiency (GIVE)
6.Law Strengthens FDA
(1) http://www.fda.gov/oc/initiatives/advance/

Continue reading "In the spotlight: FDA key initiatives" »

COI- a topic of intense current importance to NIH

From the front page of the 'NIH Record' dated July 25, 2008, (1) a new story about the Ethics Grand Rounds (2) called on NHLBI's (National Heart, Lung, and Blood Institute) Dr. Nancy DiFronzo and the University of Pennsylvania’s Dr. Arthur Caplan to tackle, in microcosm, a topic of intense current importance to NIH at large—how to manage conflict of interest in the grantee community.
The subject drew a full house in Lipsett Amphitheater. Dr. David Wendler, head of the unit on vulnerable populations in the Clinical Center’s department of bioethics said:

'Questions about financial interests are becoming more and more prominent.'

Within the last decade or so, more than 70% of drug trials have shifted from academic settings to the private side. In this context, NIH’s response to COI is important to the scientific community.
(3)
The 'NIH Record', founded in 1949, is the biweekly newsletter for employees of the NIH. Published 25 times each year/circulated to more than 20,000 readers.
(1)http://nihrecord.od.nih.gov/newsletters/2008/07_25_2008/story2.htm
(2)http://www.bioethics.nih.gov/courses/ethgr.shtml
se the April 2 2008 videocast
(3)http://grants.nih.gov/grants/policy/coi/index.htm
NIH has had a longstanding interest in objectivity in research and financial conflict of interest. We have initiated this web site to provide information on this important topic. We will continue to add to and update this web site. Readers are encouraged to check back periodically.

August 5, 2008

GAO examines FDA oversight of promotion of drugs for off label uses

July 2008, US GAO published, 'Prescription Drugs FDA’s Oversight of the Promotion of Drugs for Off-Label Uses', a Report to the Honorable Charles E. Grassley, Ranking Member on Finance , US Senate. (29 pp + appendices)

Drug companies provide medical professionals and consumers with information about prescription drugs in a variety of ways such as direct to consumer advertising on TV or the Internet, presentations by drug companies sales representatives and patient brochures provided in doctors’ offices. Although drug companies are permitted to promote their drugs, these promotions may not be false or misleading and must comply with applicable laws and regulations. FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC) has responsibility for overseeing materials an d activities that promote prescription drugs and identifying potential violations.

FDA prohibits drug companies from promoting drugs for off-label uses, that is, for a condition or patient population for which the drug has not been approved or in a manner that is inconsistent with info found on the approved drug label. Although doctors may prescribe drugs off label it is not permissible for drug companies to drugs for off-label uses. Concerns about the off-label use of drugs and associated promotions have mounted in recent years, instances of patients being improperly medicated and consequently injured have been reported back. This GAO examination was limited to FDA’s oversight of human drugs, they did not examine FDA’s oversight for promotion of other types of products under FDA’s jurisdiction.

GAO reported its findings, included the following:
FDA oversees drug promotion for off label use by reviewing promotional materials that drug companies submit to the agency. Its oversight occurs within the broader process that targets a variety of promotional violations. FDA reports that it is unable to review all submissions due to volume and does not prioritize review but relies on staff to sort through the volume of submissions and to select submissions for review...In 2006 GAO recommended that FDA track which materials it reviews. GAO also stated that FDA lacks a standardized tracking system to monitor its review efforts...FDA raised concerns with GAO’s assessment that FDA does not systematically prioritize all of the promotional materials it receives. FDA also stated that a tracking system would not improve the agencies ability to identify promotional violations. GAO also found the FDA does not screen all promotional materials.
FDA/ DOJ have taken regulatory and enforcement actions against drug companies in response to off-label promotions. During calendar years 2003-2007 , FDA issued 42 regulatory letters in response to off-label promotions requesting drug companies to stop dissemination of violative promotions. FDA took an average of 7 months to issue these letters from the time it first drafted them.... While FDA did not refer any of the violations to the DOJ for enforcement action during this period, DOJ settled both civil and criminal cases that involved at least in part off label promotions. These actions were initiated as a result of violations identified by sources other than FDA and resulted in 11 settlements.

(1)http://www.gao.gov/new.items/d08835.pdf
GAO-08-835

August 6, 2008

CDPHP Fined $600,000

Hard on the heels of HealthNow's million dollar fine, the State Insurance Department has fined CDPHP $600,000, reported in today's Albany Times Union:

Capital District Physicians' Health Plan has been fined $600,000 by the state for not telling members they could appeal denied claims, the Insurance Department said Tuesday.

CDPHP was cited when some of its lines -- its HMO product and several policies run by subsidiary Universal Benefits Inc. -- failed to provide this information for 121,911 claims submitted between 2004 and 2006, the department said.

Read the TimesUnion article here. Disclosure: the contributor of this post is employed by CDPHP.

Study: Providers' Blogs Frequently Cross the Privacy Line

A study of health care providers' blogs conducted by Dr. Tara Lagu of the Robert Wood Johnson Foundation yielded some interesting findings:

We identified 271 medical blogs. Over half (56.8%) of blog authors provided sufficient information in text or image to reveal their identities. Individual patients were described in 114 (42.1%) blogs. Patients were portrayed positively in 43 blogs (15.9%) and negatively in 48 blogs (17.7%). Of blogs that described interactions with individual patients, 45 (16.6%) included sufficient information for patients to identify their doctors or themselves. Three blogs showed recognizable photographic images of patients.

The abstract of the article is available free online at SpringerLink.
The LA Times covered the article August 4, 2006, here.

2008 UN Report on Global AIDS epidemic

The UNAIDS report clearly shows that stronger measures are needed to turn the epidemic around and that ‘knowing your local epidemic’ remains critical to an effective response.(1)
The 2008 Report on global AIDS epidemic is a report from the Joint UN Programme on HIV/AIDS (UNAIDS) and includes contributions from 10 UN system organizations brought together in the AIDS response effort of UNAIDS.(2) The Report: -confirms that the world is making some real in its response to AIDS, but 27 years into the efforts AIDS continues to challenge all efforts. Today for every 2 people who start taking the antiretroviral drugs, another 5 become newly infected. This 2008 Report: -is the most comprehensive ever, reflecting input from countries about what works and why. -asks whether the right actions are being taken, are the right actions being undertaken in the right manner, and have these actions been sufficiently scaled to make a difference. To answer these q’s, the Report relies heavily on data reported to UNAIDS by 147 UN Member States in early 2008-- on 25 core UNGASS indicators, using evidence to assess progress.
P19 shows a useful table of national indicators for the implementation of the Declaration of Commitment on HIV/AIDs referring to programmes, knowledge and behavior and impact of the indicators. Civil society monitors progress. Since HIV was first recognized, approaches and methodologies to monitor the epidemic and the response have continuously improved and as a result the world is better equipped than ever to estimate HIV prevalence, rate of new infections, to determine the extent of programme coverage, to characterize and evaluate national responses and to gauge the level of funding available for HIV programmes in low/middle income countries.Key weaknesses include countries that monitor/evaluate but have no HIV database and 1 in 4 countries with monitoring/evaluating have not calculated budgetary req’ts. The number of monitoring/evaluating countries continues to grow but they must ensure that they actually use the info generated to improve decionmaking.
P67-68 HIV is a biological entity that is responsive to medical interventions, but the epidemic has continued to expand largely due to failures to tackle societal conditions that increase HIV risk and vulnerability. 2 sets of societal factors that have not been effectively addressed in most countries: -gender equality and empowerment of women and girls, and -discrimination, stigma and social marginalizations. A human rights approach to HIV ensures that matters that are often considered discretionary are recognized as legitimate entitlements of all individuals, it empowers people to know and claim their rights and it helps stakeholders to address power imbalances that exist at household, community and national levels.
P132 The impact of retroviral drugs on the management of HIV infection has been startling, with improvements in health proving to be far more marked and enduring than anticipated when the combination antiretroviral therapy first emerged in the 1990’s. Recent studies in Denmark suggest that a young man diagnosed with HIV is likely to live an additional 35 years with available medications, a tripling of life expectancy of people with HIV. (Lohse 2007). The best time to initiate antiretroviral therapy remains a subject of debate.
P155 Focused efforts are required to ensure that all people needing treatment have equal access civil society-- surveys confirm that many people living with HIV face considerable obstacles to accessing HIV treatment (Human Rights Watch). For example several countries stipulate the young people living with HIV must obtain parental consent before receiving antiretroviral drugs. One report indicates that names of people who appear on the Russian Federation’s national registry of drug users often results in discrimination in service access for HIV positive people.
See also an ‘Evidence for action’ table on p160. (1)http://www.un-ngls.org/site/article.php3?id_article=548 (2) http://www.unaids.org/en/KnowledgeCentre/HIVData/GlobalReport/2008/2008_Global_report.asp 7 chapters, 212 pp plus annex,supplementry errata sheet. Contributors: UN Office of High Commissioner for Refugees, UN Children’s Fund, World Food Programme, UN Development Programme, UN’s Population Fund, UN Office on Drugs and Crime, International Labor Organization, UN Educational, Scientific and Cultural Organization, WHO,World Bank, Global Fund to Fight TB+Malaria, UNGASS Civil Society Steering Committee

Continue reading "2008 UN Report on Global AIDS epidemic" »

August 7, 2008

CIGNA, Express Scripts Settle AG's Drug-Switching Claims for $27 Million

From an Express Scripts news release July 29:

Express Scripts, Inc. (Nasdaq:ESRX) announced today that it has settled a lawsuit by the State of New York relating to contracts that it and CIGNA had to provide pharmacy benefit management services for the New York State employee health plan, called the Empire Plan. The plan serves New York state and local government employees, retirees and their dependents.

The full press release is here.

August 8, 2008

HHC Board Member Resigns Amid Questions

From today's NY Times:

A board member of New York City's Health and Hospitals Corporation resigned on Thursday, after the agency began an inquiry into his role in securing a 10-year, $100 million contract for a Caribbean medical school where he has long had a paid position.

Read the full story here.

A Michigan Hospital's HIPAA Kerfluffle

Michigan Governor Jennifer Granholm

It seems like nosy hospital employee stories are increasingly in the news:

The state of Michigan says it is investigating a hospital where employees improperly looked at Gov. Jennifer Granholm's medical records.

The AP story is here.

The Detroit Free Press provides more detail in an August 6th article:

Employees of Sparrow Hospital were fired or disciplined in July after it was discovered they attempted to access computerized medical information about Gov. Jennifer Granholm when she was admitted there for abdominal surgery April 29, the Free Press has learned.

A hospital spokesman said an unspecified number of employees were disciplined but would not provide details.

The rest of the Free Press article is here.

At least one hospital worker, though, claims to have been unfairly fired as a result of the incident, illustrated in this excerpt from an interview conducted by a local news station:

The [employee] says the governor was entered in the system under the name Carol Smith. She says if she did look at the governor's account, she was just doing her job.

Worker: "Someone can call and ask if someone is there, or someone can stop in and ask for somebody, and you look them up by name."

She says she looks up dozens of people a day and can't even remember if she saw Carol Smith's records, but she's positive she never saw any records with Governor Granholm's name anywhere on them.

The full transcript is here. The local news story didn't say what the fired worker's role was. Under HIPAA, access rights are supposed to be role-based, with employees having access only to those portions of the medical record necessary for them to do their job. A receptionist with responsibility to provide directory information to public callers wouldn't necessarily need access to clinical information. If the hospital's system allowed the receptionist to view information she didn't need to see, the hospital may also be in line for some discipline.

Photo courtesy of Governor Granholm's website.

1199/SEIU Wants To Legislate Home Health Aide Pay

According to the New York Times,

George Gresham, president of the 300,000-member union, insists that 1199 does not need any additional state funds to reach a settlement to raise what he says are often scandalously low wages. He said that what the union was seeking from Albany was legislation or regulations that require home care agencies to share more of their money with their workers.

The Times Article points out that 1199 typically asks for "tens of millions of dollars" for hospitals and nursing homes. Read the full article here.

August 10, 2008

CDER : certain COI aspects+the 1998 perspective.

From CDER's 8/8/08 email news:
The Center for Drug Evaluation and Research’s (CDER) recently published/made effective 7/1/2008 CDER’s MAPP 4641.3 ( superseding MAPPs dated 9/23/96 and 3/23/98). This CDER’s MAPP (Manual of Policies and Procedures) published by CDER’s Office of Management on Outside Activities describes policies regarding outside activities in CDER and specifies the responsibilities and procedures for requesting and authorizing outside activities or employment. (1) It applies to all regular CDER employees, all employees detailed to CDER and PHS Commissioned Corps personnel assigned to CDER programs.
Outside activity is any activity, compensated or not, initiated by an employee (not in response to official direction) during an employee’s personal off duty time, not using Agency’s resources and performed outside FDA premises, for which FDA COI Regulations require advance administrative approval.
Outside activities requiring prior approval generally include for example professional or consultative services, (including service as an expert witness); teaching, speaking, writing or editing that relates to official duties; service to a non federal entity as an officer, director or board member or as a member of a group, such as a planning commission , advisory council etc or employment undertaken at invitation of a prohibited source of FDA.. Prohibited sources include any source involved in activities such as seeking official action by the Agency, doing business with or seeking to do business with the Agency, conducting activities regulated by the agency, etc.
FDA’s “Policy” as set forth in this MAPP reflects additional important parameters. For example, outside activities will be approved ordinarily when they do not adversely affect the performance of an employee’s official duties, constitute a potential COI or appearance of COI, or create an adverse effect on the image of FDA. Or also employees may not work for compensation to help a person, institution, or government unit prepare or aid in preparation of grant applications, contract proposals etc.
This MAPP’s section on “Responsibilities and Procedures” also provides important information and guidance for employees in this policy area, including that employees must become familiar with and observe rules set forth in the Standards of Ethical Conduct for employees of the Executive Branch, the DHHS Standards of Conduct and the FDA COI rules.
MAPP References include helpful links to websites including for example FDA Staff Manual Guide; US Office of Gov’t Ethics; Standards of Ethical Conduct for Employees of the Executive Branch 2002 at 5 CFR part 2635, 2005 at 5 CFR Part 5501 Chapter XLV, FDA Ethics Program Annual Report on Outside Activity.
http://www.fda.gov/cder/mapp/4641.3.R.pdf 7 pages
(2)http://www.fda.gov/cder/pike/Special2002c.htm
See below the fold for an historical perspective on avoiding COI, specifically in reference to the 3/23/98 CDER MAPP 4641.3 in News Along the Pike--Special Edition 'Jim Morrison's Ombudsman's Corners Part 2: 1998. He concludes that ' An intellectually honest scientist is the most valuable asset the Agency can have.'
News Along the Pike contains all the essays written by Jim Morrison, the ombudsman for the Center for Drug Evaluation and Research from 1995 to 2003. 'His thoughtful and provocative Ombudsman's Corner has served as a guiding light to the Center during an extraordinary period in the evolution of drug regulation in the United States. '

Continue reading "CDER : certain COI aspects+the 1998 perspective." »

August 11, 2008

Hospital Infections: Point, Counterpoint

A few weeks ago (July 11-25) former New York lieutenant governor Betsy McCaughey - - now of the Committee to Reduce Infection Deaths - - and Ken Raske of the Greater New York Hospital Association traded barbs in the Albany Times Union over New York hospitals' progress on infection rates.

Continue reading "Hospital Infections: Point, Counterpoint" »

August 20, 2008

State Cuts Hospital Aid by $200 Million

The New York Times is reporting today that budget negotiations extending yesterday into the late evening include a significant reduction in state aid to hospitals.

The deal reached Tuesday night includes cuts in aid to hospitals that will probably be in excess of $200 million over the next 18 months, when federal matching funds are included, legislative leaders said.

The reduction in aid is a significant portion of the $1 billion that was trimmed from the budget overall in yesterday's session.

The full NYT piece is here.

August 21, 2008

2 New FDA websites:Health Professionals Website(interactive)+ Andy's Take(issues discussed)

August 2008.

FDA recently launched a new Health Professionals web page as part of a larger effort by the agency to increase interactions and communications with health professional organizations. The webpage provides useful, timely, and accessible information to the nation's physicians, nurses, pharmacists, and other members of the health professional team.

For example, today's front page spotlights include an educational article prepared by a contractor entitled: 'Improved Prescription Drug Labeling' as well as FDA official information notices, 'Possible Malfunction of Electronic Medical Devices Caused by Computed Tomography (CT) Scanning', and 'Information on the Safety of Gardasil Vaccine-Summary of Gardasil vaccine safety monitoring activities and findings'.
Organization of this webpage for FDA info is easy to use: for example, see focus areas like 'Recalls & Approvals', 'Recalls & Safety Alerts', 'Drugs', 'Medical Devices', 'Biologics, ''Radiologics Health', 'Food Safety, Nutrition & Cosmetics' . These sections link to specific topical articles or broader related FDA webpages.
With a science based call to action, we need FDA's vast technical information and policy resources. This functional guide will help readers tailor their web search from visit to visit, and save time in finding out what is happening at FDA or what FDA is doing or what FDA has done already.
Helpful sidebars provide for 'Most popular' FDA links, or 'Updates'. Some of the many useful Related Resources provided are:
Prescribing Information (NIH)
Medication Errors
ClinicalTrials.gov
Tutorials & Continuing Education
'About Andy’s Take' is another new FDA communication effort showcased August 15.
Through this communications column on the FDA Web site, Commissioner for Food and Drugs Andrew von Eschenbach will discuss weekly FDA issues of interest to the American consumer and occasionally preview upcoming FDA issues and events.

(1)http://www.fda.gov/healthprofessionals/
(2)http://www.fda.gov/oc/vonEschenbach/andys_take/default.html

Health Law Section Fall Meeting

Join your friends and colleagues at the October 18th meeting of the Health Law Section. This year's program offers 6 MCLE credits including two hours in ethics. Topics include: Anatomy of An Internal Investigation, How is an Investigation Conducted, How Do You Protect Attorney Client Privilege, When Do You Seek Outside Expertise, Ethical Considerations: What do You Do With the Results.

The program will be held at the historic Gideon Putnam Hotel. The Gideon is nestled within the towering oaks and pines of the picturesque Saratoga Spa State Park. The hotel combines historic character with exceptional service and modern facilities.

View the program and registration materials at www.nysba.org/HealthFallMtg08. The cutoff date for reservations at the Gideon Putnam is Thursday, September 18. Make plans now to attend.

August 22, 2008

FDA and The International Conference on Harmonization (ICH) initiatives of the EU, Japan and the US.

From CDER email news today:

In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote international harmonization of regulatory requirements. FDA has participated in many meetings designed to enhance harmonization and is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify and then reduce differences in technical requirements for drug development among regulatory agencies. ICH was organized to provide an opportunity for tripartite harmonization initiatives to be developed with input from both regulatory and industry representatives. FDA also seeks input from consumer representatives and others. ICH is concerned with harmonization of technical requirements for the registration of pharmaceutical products among three regions: The European Union, Japan, and the United States.

FDA recently announced in Federal Register notices the availability of draft guidances prepared under the auspices of the ICH of Technical Requirements for Registration of Pharmaceuticals for Human Use.(1) Comments on them are most useful if submitted by November 3, 2008.
One of these four FDA Draft Guidances describes format, content, and timing of a development safety update report (DSUR) for an investigational drug. The DSUR would serve as a harmonized, annual clinical trial safety report that would be standard among the 3 ICH regions. DSUR is intended to promote a consistent approach to annual clinical safety reporting among ICH regions and enhance efficiency by reducing the number of reports generated for submission to regulatory authorities. Entitled, 'E2F Development Safety update Report' (dated June 5, 2008), here are a few excerpts:
The periodic analysis of safety information is crucial to ongoing assessment of risk to trial subjects during clinical development of an investigational drug. It is also important to notify regulatory and other interested parties (ie ethics commitees) at regular intervals of the evolving safety profile of an investigational drug and actions proposed or being taken to address safety issues. DSURs would be a common standard for annual clinical trial safety reporting in any ICH region....The main focus of the DSUR is data from interventional clinical trials of investigational drugs, including biologicals, with or without marketing approval whether conducted by commercial or non-commercial sponsors... DSUR data should be submitted no later than 60 calendar days from the DSUR data lock point--this date is based on the date of the sponsor's first authorization to conduct a clinical trial in any country (the 'Development International Birth Date', DIBD).

The Sponsor of a clinical trial is responsible for preparing the DSUR but many relationships/responsibilities typical in drug discovery/development research are discussed in terms of the proposed DSUR. For example, 'Shared Responsibilities' include situations where an individual clinical trial or drug development programme involves collaboration with public or private institutions , business partners or other parties and states that a written contract should be in place detailing responsibilities for preparation and submission of the DSUR. This requirement is applicable to situations where a sponsor delegates the preparation of the DSUR to a 3rd party (e.g. CRO)(2)
(1)http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-17861.pdf(2)http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0386-gdl.pdf (26 pp + appendices)
See below the fold for who is involved in this particular ICH.

Continue reading "FDA and The International Conference on Harmonization (ICH) initiatives of the EU, Japan and the US." »

Federal Home Loan Banks (FHLB) Eligible to Issue Letters of Credit

The FHLB system is a government sponsored enterprise (GSE) consisting of twelve cooperatively owned institutions that are regulated by the Federal Housing Finance Board. In 1984, Congress banned so-called "federal guarantees" of tax-exempt bonds by all but a handful of GSEs. The IRS ruled that this ban applied to FHLBs. Section 3023 of the housing aid bill reverses this ban by amending Section 149(b)(3) of the Internal Revenue Code to add guarantees by a Federal home loan bank for new tax-exempt bonds to the list of exempted GSE guaranties. This change provides hospitals who are seeking to finance projects with tax-exempt bonds with another source of credit enhancement.

August 25, 2008

Joint Hearing on Out-of-Network Insurance Coverage

The Insurance Department and Department of Health will hold a joint hearing on out-of-network insurance coverage on October 7, 2008 in Albany.

In response to complaints from consumers who did everything they could to use in-network doctors, but nonetheless received surprise bills from specialists whom the consumers did not know were out-of-network, the Insurance Department will hold a public hearing with the Department of Health, Insurance Superintendent Eric Dinallo announced.

The Insurance Department and Department of Health are considering statutory and regulatory changes to address issues related to out-of-network coverage and would like to receive input from consumers, health plans, providers and other interested parties.

The public hearing is scheduled as follows:

Date: Tuesday, October 7, 2008
Time: 10:00 AM
Location: Empire State Plaza, Meeting Room 1, Albany, New York

August 26, 2008

Governor Freezes Malpractice Rates

From an August 22 Department of Health press release:

Governor David A. Paterson today announced that he has signed legislation to freeze medical malpractice rates for physicians in New York for one year in an effort to provide desperately-needed premium relief for doctors already overburdened by soaring premiums. The legislation will also allow the state additional time to continue its work to develop a long-term solution to the medical malpractice problem confronting the state.

Read more here.

Governor Signs Nurse Overtime Legislation

The legislation previously reported here regarding nurse overtime was signed by Governor Paterson, as announced in an August 15 Department of Health press release:

Governor David A. Paterson this week signed legislation to ban mandatory overtime for nurses in hospitals and other health care facilities, including those operated by the State. This important law will significantly decrease the risk of serious, preventable medical errors brought upon by fatigued and overworked nurses.

. . .

This new law will prohibit health care facilities from requiring nurses to work more than their regularly scheduled work hours, but does not place a specific cap on the number of hours that can be worked per day or week. The bill contains exceptions to the mandatory overtime prohibition for the following situations:

  • Natural or other types of disasters that increase the need for nursing services
  • A federal, state or county declaration of emergency
  • A nurse engaged in an ongoing medical or surgical procedure
  • When necessary to provide safe patient care where no other alternative staffing is available; and
  • A nurse voluntarily agrees to work overtime
Read the press release here.

About August 2008

This page contains all entries posted to HEALTH LAW SECTION BLOG in August 2008. They are listed from oldest to newest.

July 2008 is the previous archive.

September 2008 is the next archive.

Many more can be found on the main index page or by looking through the archives.