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Darzi’s Five Pledges Are Positive But Need Detail, Says British Medical Journal, UK

May 9th, 2008

Five pledges on NHS reform in England announced by health minister Lord Darzi today (Friday 9 May, 2008) are positive in principle, but there are signs that they are so far not being met in practice, the BMA says.


Commenting on the ‘Leading Local Change’ document, published ahead of regional reports from Strategic Health Authorities on NHS reform, and Lord Darzi’s final report, Dr Hamish Meldrum, Chairman the BMA, says:


“These principles are all positive - in fact they’re impossible to disagree with. Of course it’s right that changes should always be to the benefit of patients, that they should be evidence-based, and that local populations should have a meaningful say over their NHS services.


“The problem is that the public and healthcare staff alike have yet to see much evidence of these principles being delivered up to now.


“As part of the initial Darzi review, it appears that every Primary Care Trust will have to meet a centrally imposed requirement to have a new ’supersurgery’. This is despite a lack of sound evidence to show that they all need one, or that proper local consultation is always taking place.


“Lord Darzi’s pledges are sound but require detail - we need to see much more flesh on the bones. The impact of these reforms will ultimately depend on such details - on the way they are taken forward locally, and on the nature of engagement with staff and the public. We will be scrutinising the outputs from the regional groups to try to make sure that these principles are really being borne out in practice.


“The BMA has already produced detailed proposals on both an NHS Constitution and Public and Patient Involvement which we believe would give detail and teeth to the minister’s principles and help to ensure that the local public and clinicians really have a voice in the range and quality of the services being provided.”


Juliet Dunmur, Chair of the BMA’s Patient Liaison Group, adds: “The involvement of patients and the public has been patchy, and the quality of consultation has varied considerably. At the moment, there simply isn’t the infrastructure to give patients a genuine voice in these changes. The new patient organisations introduced last month have not yet had an opportunity to get underway with their work.”


1) The BMA’s proposals for an NHS constitution and improved Public and Patient Involvement are available here.



2) The BMA is holding a series of regional meetings in each Strategic Health Authority to enable local doctors to discuss planned changes in their area: Dates confirmed so far are:


- Eastern 28 May 2008

- Southern 11 June 2008

- East Midlands/Trent 11 June 2008 (Lincoln)

- South West 16 June 2008

- West Midlands 18 June 2008

- Yorkshire 17 June 2008


British Medical Association

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Purdue Expert Offers Tips On Spring Cleaning The Medicine Cabinet

May 9th, 2008

When cleaning out the medicine cabinet, medication and drugs should not be thrown in the trash or flushed down the toilet, says a Purdue University expert.
Patricia Darbishire, a clinical assistant professor of pharmacy practice, recommends that before disposing of any medication people contact a local pharmacist, the Solid Waste Management District or a law enforcement agency to learn the proper disposal technique for your geographic area.


“There is concern about pollution of the water supply through sewers and landfill runoff,” she says. “Most tablets can be crushed, capsules opened and liquids mixed with cat litter, sawdust or flour to prevent misuse, and then sealed in a plastic bag or milk carton and disposed of in the trash. This will reduce the amount of chemicals that can leach out from landfills during heavy rains.”


Discard medications that are past the expiration date, Darbishire says.


“A general rule of thumb is that most prescription medication is good for a year after leaving the pharmacy, unless labeled otherwise,” she says. “You can ask the pharmacist to check the expiration date on the pharmacy stock bottle to be certain. Be especially mindful of liquid medications, which may separate and result in an incorrect dosage in products with multiple ingredients.”


Do not stockpile medications for future use.


“Discard drugs that you are currently not prescribed,” she says. “Specific infections require specific antibiotics. It is not likely that the one you kept will work, especially if you only have a partial supply. By selecting the wrong antibiotic and using a sub-potent dose, you are contributing to the development of resistant strains of bacteria.”


If a medication has an illegible label or the container is broken, discard the product to prevent the medication from being taken incorrectly or mistaken for another product.


“Products in broken containers may not be sealed properly and could become unstable,” Darbishire says. “Also, a broken container or cap makes it easier for young children to become victim to poisoning.”


Store medications in a cool, dry place away from extreme temperature changes and humidity.


“If you keep your medications in the bathroom, above a stove or near a dishwasher, you may expose them to high humidity and temperature changes,” Darbishire says. “This could lead to product breakdown, which may cause medication to become less effective over time or to convert to a completely different chemical that may be dangerous for consumption. An appropriate location for your medications might be the bedroom, an upper kitchen cabinet or any other cool, dry place to ensure they are out of reach of small children and animals.


Writer: Elizabeth Gardner


http://www.purdue.edu

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Report Details Inner Workings Of Growing MTM Clinic

May 8th, 2008

Clinicians working in an outpatient pharmacy clinic in Chicago are hoping to build relationships with patients that will lead to improved continuity of care, according to a report in the May 1 edition of American Journal of Health-System Pharmacy. The report describes the patient care center as a successful, growing program with goals of improving medication access and adherence, continuity of care and patient education.


The mission of the University of Illinois Medical Center at Chicago (UIMCC) outpatient pharmacy clinic is to help patients with multiple chronic conditions manage their drug therapies to improve their health and decrease drug-related problems. Many UIMCC patients are indigent and qualify for Medicare benefits.


The MTM patient care model used by the referral-based clinic is “intensive and comprehensive,” according to the report. Patients are referred to the clinic from UIMCC healthcare professionals using admission criteria that include difficulty in self-managing medications and adhering to long-term medication regimens. Currently, the clinic serves up to 150 patients per year, up from about 30 patients in 2001. Between nine and 13 patient visits are scheduled each day. The clinic, which operates during business hours on weekdays, generates about 90 prescriptions a day for the outpatient pharmacy.


During a normal day, a minimum of two MTM pharmacists and one pharmacy technician staff the clinic. Pharmacists at the clinic also work as faculty members at the University of Illinois at Chicago, and have research and teaching responsibilities. Three of the five pharmacists also work at other clinics.


Click here to read the full report.


American Society of Health-System Pharmacists

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Lord Darzi Sets Out Tough Rules For Changes In The NHS, UK

May 8th, 2008

Five pledges will ensure that change is transparent and driven by the
best evidence

Leading clinician and Health Minister Lord Darzi today issued five
pledges to the public and staff on how the NHS will handle changes to
services. He set out a rigorous process requiring any change to be
transparent, clinically evidenced, locally led and for the benefit of
patients.

Lord Darzi’s report ‘Leading Local Change’ comes ahead of his final
report on the next stage of NHS reform.



This new report, aimed at the public, patients and staff, signals
that whilst the NHS must never back away from necessary change to
improve services and save lives, there should be important checks
which any change has to undergo before it proceeds. That is why today
we are making five pledges on change in the NHS, which PCTs will have
a duty to have regard to:

1. Change will always be to the benefit of patients. This means that
change will improve the quality of care that patients receive -
whether in terms of clinical outcomes, experiences, or safety.

2. Change will be clinically driven. We will ensure that change is to
the benefit of patients by making sure that it is always led by
clinicians and based on the best available clinical evidence.

3. All change will be locally-led. Meeting the challenge of being a
universal service means the NHS must meet the different needs of
everyone. Universal is not the same as uniform. Different places have
different and changing needs - and local needs are best met by local
solutions.


4. You will be involved. The local NHS will involve patients, carers,
the public and other key partners. Those affected by proposed changes
will have the chance to have their say and offer their contribution.
NHS organisations will work openly and collaboratively.

5. You will see the difference first. Existing services will not be
withdrawn until new and better services are available to patients so
they can see the difference.



Lord Darzi said:



“The nature of healthcare means services will always need to change,
and sometimes that means re-organising how services are provided.

“Our nationwide listening events have shown me that patients, the
public and NHS staff are not opposed to change in principle but want
to ensure it is done to save lives and improve quality and is not
driven by cost or politics.

“This is not about change for change’s sake. It’s about change for
the right reasons, improving quality of care for patients and saving
lives. These pledges mean change will be locally-led,
clinically-driven and evidence-based. And an independent high
clinical bar for change should reassure local people everywhere that
we mean what we say.”

“The right way of doing this is to put local clinicians in the lead,
with the public and relevant independent experts consulted and
involved at an early stage. Ensuring that changes are based on the
strongest clinical evidence and are relevant to their local
communities. The role of national bodies has to be to support local
clinicians with the best evidence.

“We are putting in place a process that ensures the local NHS
rigorously checks proposals for change to ensure they meet the
highest standards. The principles and guidance published today sets
out how, where necessary, the NHS will make changes that will lead to
real improvements for everyone - changes that are based on clinical
evidence and supported locally by patients and the public.

“The focus of my report on the next stage of NHS reform will be how
we can enable local clinicians and patients to be the driving force
of improvement and change in the NHS. These proposals I am setting
out today are only the first part of that. Empowered patients and
empowered staff are the key to world-class standards”.

The detailed operational guidance also published today, Changing for
the Better, builds on the work set out in Sir Ian Carruthers review
of service change and reconfiguration proposals published last year.

Since the start of the Review in July last year, Lord Darzi and his
team across the country have been engaging widely with patients, the
public and staff working in the NHS and other local organisations.
Over 60,000 people have participated in the Review including nearly
2,000 frontline clinicians and other staff who worked as members of
the clinical pathway groups.

Every area of the country will publish a clinicially led vision
document over the next month, setting out priorities for improving
health and healthcare over the next decade. Lord Darzi’s final Review
report will be published in June. It will focus on enabling and
supporting the changes agreed locally by patients, the public and NHS
staff.

1. Leading Local Change, published today under embargo, can be found
at http://www.ournhs.nhs.uk The document refers to eight key steps
to deciding on substantive service changes to make the five pledges a
reality. These eight steps are included in detailed operational
guidance Changing for the Better also published today under embargo.
They are:-

(i) Driven by clinical need Your local NHS will carry out a planning
and needs assessment led by local clinicians. This will look at
current services and how they fit with the latest developments in
clinical practice and current and future needs of patients.

(ii) Early involvement in proposals. Based on the understanding of
clinical needs, your local NHS will develop proposals for improving
services, in conjunction with Local Authorities, the local third
sector, local stakeholders and the public - ensuring that local
people have the chance to have their say early on in the process, and
that all proposals respond to their needs.

(iii) A high clinical bar for change. All proposals will be subject
to independent clinical and management assessment. We will make this
possible through the Office of Government Commerce’s Gateway Review
process. This is a process of peer review that identifies risks and
issues at an early stage. This process will be supported by the
National Clinical Advisory Team, whose membership will be drawn from
members of the Clinical Working Groups. This means there will be a
high clinical bar for change everywhere in the NHS, so that change is
always to the benefit of patients.

(iv) Listening to you. There will be a formal period for everyone
affected by a substantial change to have their say. Public
consultation on the proposals for change will take place normally for
a minimum of 12 weeks, although it may be possible to reach local
agreement about a different timescale where appropriate. This will
mean patients, the public and staff will be involved in the process.

(v) Responding to you. The local NHS will analyse what you have said,
helping to inform, shape and strengthen local proposals for change.

(vi) Local decision. A decision on whether to go ahead with the
proposed changes will be taken locally, based on the clinical and
management case put forward, the benefits for patients and
consultation responses. When the other steps are taken, we are
confident that the local decisions will be the right ones for local
people.

(vii) Making sure it’s right. The Local Authority, through its
Overview and Scrutiny Committee, may review and scrutinise the
proposal. We believe that local issues need local solutions, so we
are exploring options for the introduction of local mediation where
multiple Overview and Scrutiny Committees in a Joint Overview and
Scrutiny Committee cannot agree.

(viii) Appeal. The Overview and Scrutiny Committees will reserve the
right to refer the decision to the Secretary of State for Health if
they believe that the proposal is not in the interests of local
health services. The Secretary of State may then ask for expert
advice from the Independent Reconfiguration Panel, whose advice will
be made public.

2. Lord Darzi’s review was announced by Health Secretary Alan Johnson
on 4 July 07
see here

3. Lord Darzi’s interim report was published on 4 October 07 and can
be found
here.


http://www.dh.gov.uk

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Senate Subcommittee Votes To Boost FDA Funding By 275 Million Dollars

May 8th, 2008

In an important first step towards achieving increased funding for the Food and Drug Administration (FDA), members of a Senate appropriations subcommittee approved an additional $275 million in appropriations for the agency.


The additional resources would provide a significant boost to the FDA’s ability to monitor drug safety. The nearly $100 million earmarked for medical product and drug safety activities would allow the agency to implement many new drug safety initiatives required by the recent Food and Drug Administration Amendments Act, including pediatric drug and device safety, post-market study commitments, and improved drug surveillance and labeling.


The proposed funding increase would also allow the FDA to improve its information technology systems to more rapidly identify adverse drug events and strengthen its ability to conduct inspections of foreign and domestic medical product facilities as well as examinations and lab analysis of imported medical products.


ASHP is an active member of the Alliance for a Stronger FDA, a broad group of patient groups, consumer advocates, biomedical research advocates, health professionals and industry officials, who work to assure the FDA has sufficient resources to protect patients and consumers. The Society participated in a lobby day activity last month to make the case to legislators about the need for additional funding.


A similar proposal will be considered this week by the House of Representatives.


American Society of Health-System Pharmacists

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Patients, Doctors, Pharmacists Praise Bipartisan House Resolution On Compounded Hormones Containing Estriol

May 8th, 2008

The International Academy of Compounding Pharmacists joined hundreds of thousands of women and doctors in applauding the introduction
of H. Con. Res. 342, a bipartisan resolution stating that “the Food and Drug
Administration’s (FDA) new policy restricting women’s access to medications containing
estriol does not serve the public interest” and calling on the FDA to “reverse its policy.”


Reps. Mike Ross (D-Ark.), Jo Ann Emerson (R-Mo.), Sam Farr (D-Calif.), Tammy
Baldwin (D-Wisc.), Michael Burgess (R-Texas), John Carter (R-Texas) and Gabrielle
Giffords (D-Ariz.) introduced the resolution in the House of Representatives.


“We commend all of the sponsors for standing up for women and introducing H. Con.
Res. 342,” said L.D. King. “Women with menopause suffer enough. Fortunately, this
resolution aims to provide them with some relief.”


For decades, doctors have prescribed compounded hormones containing estriol to women
suffering from the painful symptoms of menopause. IACP estimates that hundreds of
thousands of women are prescribed these drugs today. FDA’s policy would force these
women to discontinue the hormone treatments that their doctors have determined is
appropriate for them.


Wyeth petitioned the FDA in October 2005 to prohibit compounding pharmacists from
preparing hormones that contain estriol on the grounds that doing so posed a “serious
threat to public health.” At the same time, though, Wyeth was marketing drugs
containing estriol as “an ideal therapy” across Europe.


Wyeth’s petition generated more than 70,000 responses, the overwhelming majority of
which from women and doctors opposed to Wyeth’s request. Unfortunately, FDA
fulfilled Wyeth’s request earlier this year when it announced that it would “halt” the
compounding of compounded hormones containing estriol.


“FDA ignored the comments of tens of thousands of women and instead listened to
Wyeth,” continued Mr. King. “Removing this drug from the market robs patients of a
long-standing, vital and legal menopause treatment alternative to Wyeth’s products.
FDA’s policy is an unwelcome intrusion of federal bureaucrats into thousands of doctors’
offices.”


Compounded hormones containing estriol are lawfully prescribed, prepared and
dispensed in all 50 states and their use is accepted by the United States Pharmacopeia and
the Pharmacy Compounding Accreditation Board. The FDA has acknowledged that it is
unaware of any adverse events associated with the use of these drugs. Estriol is a
component of a multiple sclerosis treatment undergoing Phase II clinical trials; in
compounded form it is prescribed by doctors to treat both multiple sclerosis and
symptoms of menopause.


Since FDA announced its estriol policy in January, the agency has since attempted to
allay the concerns of thousands of women by stating that doctors may prescribe
compounded hormones containing estriol if they complete an Investigational New Drug
Application (IND). Unfortunately, this process is unworkable.


“FDA is trying to fit a square peg in a round hole,” concluded Mr. King. “FDA is setting
doctors up to fail, leaving them in the same position are they are in now - unable to treat
women with the medication of their choice.”


Pharmacy compounding is a long-standing, state-regulated and medically vital practice.
Millions of Americans have unique health needs that off-the-shelf prescription
medications cannot meet. For them, customized, compounded medications - prescribed
or ordered by licensed physicians or veterinarians and mixed safely by trained, licensed
compounding pharmacists - are the only way to better health.


About IACP


The International Academy of Compounding Pharmacists (IACP) is a non-profit
association founded in 1991 to protect and promote the art and skill of the compounding
pharmacy profession. We represent more than 2,000 pharmacists, physicians, technicians
and patients who are committed to the safe practice of pharmacy compounding. We are
committed to ensuring the rights of physicians to prescribe, of pharmacists to prepare and
of patients to take customized medications that meet their unique, individual needs.

International Academy of Compounding Pharmacists

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Wal-Mart Adds Prescription Women’s Health Medications To Discount Drug Program

May 8th, 2008


Reprinted with kind permission from http://www.nationalpartnership.org. You can view the entire Daily Women’s Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women’s Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.


© 2008 The Advisory Board Company. All rights reserved.

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Bill To Register Pharmacy Technicians Could Become Law In Florida

May 8th, 2008

Florida would become the latest state to require the registration and training of pharmacy technicians thanks to legislation going before Gov. Charlie Crist to sign into law.


Under the bill passed by Florida legislators, technicians would need to register with the Florida Board of Pharmacy by 2010. Starting in 2011, the legislation would require them to complete one of the following: a board-approved training program, 1,500 hours of work as a technician under a Florida licensed pharmacist or certification by a program accredited by the National Commission for Certifying Agencies.


The Florida Society of Health-System Pharmacists secured legislative support for the bill and helped educate state senators and representatives and their staffs on the need for technician registration and training to improve patient safety.


ASHP recently launched an initiative to work with state affiliates to advocate for state laws that require, as a prerequisite for state board registration, completion of an ASHP-accredited pharmacy technician training and Pharmacy Technician Certification Board (PTCB) certification.


American Society of Health-System Pharmacists

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Clinical Pharmacy Services Collaborative Seeks Healthcare Providers

May 8th, 2008

ASHP recently participated in a conference convened by the Health Resources and Services Administration (HRSA) to encourage healthcare providers to serve on teams in a patient safety initiative.


The formation of teams is currently under way for participation in HRSA’s Patient Safety and Clinical Pharmacy Services Collaborative. Team members will learn and adopt best practices in patient safety, clinical pharmacy services and health outcomes.


Dozens of frontline healthcare providers and healthcare organization representatives from across the U.S. attended the “Leadership and Partnering Event,” to learn how they can lead and take part in the collaborative teams.


HRSA officials told attendees that the interdisciplinary teams will work to improve the quality of patient care by integrating clinical pharmacy services into their practices and reducing drug interactions.


Kasey Thompson, director of ASHP’s patient safety and quality efforts participated on a panel and shared the Society’s commitment to the goals of the collaborative.


The Society has pledged its support to the effort and will supply the collaborative with access to AHFS drug information and other best practices resources.


ASHP will also host a networking session to highlight the collaborative during the Society’s upcoming Summer Meeting in Seattle. During the session, pharmacists who have significantly improved outcomes for patients will share their strategies.


Check for updates on the Society’s involvement in the collaborative in the Advocacy area of ASHP’s Web site, ashp.org.


American Society of Health-System Pharmacists

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Better Regulation Of Medicines Initiative - Third Report Launched, UK

May 8th, 2008

The Medicines and Healthcare products Regulatory Agency (MHRA) is to publish its third report on the new and innovative scheme; Better Regulation of Medicines Initiative (BROMI) on 08 May 2008. BROMI is a ground breaking initiative which is changing medicines regulation in order to deliver new updated medicines to patients faster.


A year long pilot initiated in February 2007 to cut the regulatory burden on Variation Applications was carried out with a small group of pharmaceutical companies to test the feasibility of moving towards a self-certification model for certain types of variations. The results were very successful and the scheme was rolled out to the pharmaceutical industry on 1 April 2008, together with reduced fees.


It is envisaged that approximately 80% of Type I notifications will be processed through the self-certification scheme, which will be a huge benefit to industry - a saving of up to £100 million - and ultimately, benefit to patients.


BROMI has shown that medicines regulation can be targeted; risk based and proportionate and still deliver high levels of patient safety. The initiative has made steady progress since its publication of the first and second reports in May and December 2006 and is committed to making an impact on medicines regulation to the advantage of all stakeholders. Importantly, the principles of BROMI are reflected in new legislation proposed by the EU Commission.


Director of Vigilance and Risk Management of Medicines at the MHRA, Dr. June Raine said ‘Our third report shows that real progress has been made since BROMI’s introduction in 2005. The MHRA is on track to cut the amount of regulatory burden on industry via license variation processes, whilst achieving its fundamental objective of always putting patient safety first.’


Notes


- As with all new BROMI ways of working, the MHRA will be exercising its enforcement role in this area and where necessary may remove company privilege where there have been breaches of the scheme.


- The roll out of the new BROMI variations scheme will include a joint MHRA/industry training day on 08 May 2008.


- BROMI was originally set up to look at how unnecessary regulatory burdens, primarily in relation to over the counter (OTC) medicines, could be eased, whilst maintaining safeguards to protect public health; however, the scope of BROMI has now been extended to the entire pharmaceutical industry.


- The BROMI team won an EU better regulation award in October 2007- the Red Tape Reduction award, hosted and presented by the Standard Cost Model Network, in competition against 21 initiatives from across the EU.


http://www.mhra.gov.uk

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