Pharmacy education centre awarded new NHS contract

A new contract between the NHS and the University of Manchester has secured the future of the Centre for Pharmacy Postgraduate Education (CPPE).

NHS North West, on behalf of the NHS as a whole, signed up to the contract with the University, safeguarding the organisation’s future funding through the Multi-professional Education and Training levy: part of the Department of Health’s investment in education and training.
Based at The University of Manchester, CPPE offers continuing professional development opportunities for pharmacists and pharmacy technicians providing NHS services in England. The organisation was described as a “centre of excellence” in 2008 following a review led by the Chief Pharmaceutical Officer, Keith Ridge, and the completion of an independent evaluation carried out by the University of Birmingham.
Neil McLauchlan, Assistant Director for Education and Commissioning, NHS North West, said: “This new arrangement gives a chance for the contract to be closer to service and engage more effectively with the wider NHS education and training networks. The new Contract Management Board will add to the robust governance arrangements that have supported CPPE when being managed by the Department of Health.”
The review recommended greater involvement of the NHS in the operation of the Centre to reflect the role, remit and funding of CPPE as part of the NHS investment in the healthcare workforce.
In the current financial climate, CPPE, like all education and training providers across the NHS, will face pressure to ‘do more for less’. The new contract provides for the Centre to develop and commercialise the intellectual property it creates in the course of delivering learning for pharmacists and pharmacy technicians.
This will include opportunities to develop partnerships with The University of Manchester and other higher education institutions. Income generated by the Centre will be reinvested in the learning programmes delivered by CPPE and will support the delivery of NHS services across England. Learning will continue to be delivered free of charge to pharmacists and pharmacy technicians in England. The Department of Health will continue to retain the copyright on all learning developed by CPPE.
Professor Dame Nancy Rothwell, the University’s Vice Chancellor and President, said: “The University recognises the importance of continuing professional development for today’s professionals and is extremely pleased that Manchester, through CPPE, is able to be at the forefront of this for the two pharmacy professions.”
Professor Ian Jacobs, Vice-President and Dean of the Faculty of Medical and Human Sciences, added: “We are delighted that the University has secured the future contract for CPPE and look forward to the opportunities and mutual benefits this will provide.”
Keith Ridge, Chief Pharmaceutical Officer, said: “I am delighted to see the final steps in securing the future of CPPE as an integral part of the NHS education and training infrastructure are in place.
“As plans to establish Health Education England and local education and training infrastructure take shape, it is important that CPPE’s commitment to working with employers, pharmacists and pharmacy technicians, across community, primary care and NHS Trusts, goes from strength to strength.
“Whilst stability and continuity in the provision of learning is as crucial now as it has ever been for pharmacy and the patients it serves, CPPE will also need to adapt quickly to support the transformational change necessary to support the quality and value that the public will demand from health services and the professionals that provide them.
“Improving outcomes through medicines optimisation, delivered in a healthy living environment, will need a level of both engagement with the public and patients, and collaboration across and within professions, not previously seen and CPPE will be an important player in supporting this new agenda.”
For information about CPPE and the learning opportunities it offers, visit www.cppe.ac.uk.

Independent pharmacy figures out how to set itself apart

THE CHALLENGE
The corner drug mart was becoming a rarity as grocery stores and megastores increasingly captured a larger share of the prescription, drugstore products and specialty gift lines of business. Competitors’ costs and prices were lower and their advertising budgets were higher. The independent corner drug mart was finding it more difficult to succeed in the shadow of these powerful competitors.

Rob Heaton, a pharmacist and owner of Cambrian Pharmacy in Calgary, realized that a change in strategy was required if his business was going to remain viable.

THE BACKGROUND

Cambrian Pharmacy opened in 1959 in a new neighbourhood in central Calgary. In 1996, Mr. Heaton purchased the store from a pharmacist-owner he’d known since high school and with whom he’d worked since 1990.

Shortly after assuming sole ownership, Mr. Heaton realized that continuing to operate a traditional drugstore was no longer viable. Change was essential for survival.

Big-box stores, like Wal-Mart Stores Inc., had a strategy of ensuring they had the best price on everything from a case of diapers to a children's book. Young families watched their money carefully and were compelled to get the best price.

Traditional drugstores also carried a significant inventory of giftware and home accessories. The opening of stores like Pier 1 and Rafters, part of the Liv Canada Gift Groupmade it difficult to compete with the drugstore's limited product lines.

As a result, Cambrian Pharmacy faced an identity crisis of sorts. Before establishing a new identity and business strategy, Mr. Heaton felt he had to answer two key questions: What are we? What's our business?

He saw himself as a health care professional, leading him to conclude that Cambrian Pharmacy's business was health care. He then had a focus for his strategy.

THE SOLUTION

In 2002, Cambrian began to offer a compounding service, essentially custom-tailoring prescriptions, in precise dosages and forms. Standard products don't work for well for some patients with a unique combination of symptoms, diseases and tolerance levels.

The compounding service started out small, with a small counter space and a simple, new piece of equipment, an ointment mill.

To create awareness of the service, Mr. Heaton held meetings with physicians to discuss their most puzzling patients. “You dream it and we'll find a way to do it,” he told them.

Working with physicians created an awareness of the value of the service and helped with word-of-mouth marketing.

The creation of individual treatment plans resulted in a holistic approach to health.

Patients were requesting natural ingredients and fewer chemicals and dyes. They were also were routinely conducting research into their ailments. After validating holistic plans, the pharmacist could work with a patient and his or her physician to develop a treatment plan.

Mr. Heaton also identified a competitive advantage that pharmacists had over their main competitor: health food stores, whose knowledge was limited to naturopathic products. Pharmacists could understand both homeopathic and prescription drug remedies and the complex interactions that might result.

THE RESULT

The role of being a “medication problem solver” is very challenging and satisfying, and fits the business's focus.

As a result, two of Cambrian’s pharmacists have pursued specialties relating to their passions and interests, one in diabetes and the other in hormone balancing and reproductive therapy.

The compounding service grew in response to customer demand and Mr. Heaton’s increasing experience allowed him to identify additional opportunities.

Over the past decade, new equipment and training have allowed the compounding service to grow from six square feet of counter space to a pharmaceutical lab occupying 400 square feet, and it is able to prepare the most complex and sterile medications (for instance, eye drops and injections).

To increase trust in its products, Cambrian voluntarily sends all of them for testing to ensure quality control. It has also developed a collection of scholarly articles and studies that can be used by physicians considering a novel treatment protocol.

Cambrian’s relationship with physicians continues to flourish as it provides unbiased information on new developments and products in the industry.

Cambrian is the pharmacy with the largest selection of homeopathic and complementary remedies in Calgary. It now has three or four pharmacists on each shift, up from one in 1996.

Mr. Heaton has demonstrated a clear strategic vision of a pharmacy providing health care choices and solutions that is built upon four key services: compounding, supplements, natural products and the pharmacy.

His motto of “If you decide to do something, do it right,” and having a passion for what he does will continue to allow Mr. Heaton to be creative and innovative.

In addition to providing superior customer service by developing individualized treatment plans, Cambrian will continue to allow patients to make informed choices about their health.

Parents, pharmacists: Crucial attention-deficit drugs scarce

Seven million people who have been prescribed drugs to battle the unmanageable cacophony that attention deficit hyperactivity disorder brings to their minds now face another hurdle: getting those drugs at the pharmacy.
Lake Park pharmacist Nirav Patel finds himself fielding nearly a dozen phone calls a day from patients frantically trying to fill prescriptions.
The owner of Robalo Pharmacy says his suppliers give him only enough to fill one or two a day.
"It's rationed out. The problem is big. It is huge," Patel said. "This is one of the biggest shortages right now."
And health authorities nationally expect the problem to worsen through the holidays and into the new year.
Th e shortages were first seen last spring, when one of the most commonly prescribed medicines, Adderall, went generic, said Ruth Hughes, chief executive of the national advocacy group Children and Adults with Attention Deficit/Hyperactivity Disorder.
"There were lots of problems: distribution issues; issues of production involving the active pharmaceutical ingredient," she said. "We talked to a number of people at the time who thought it was going to be a short-term problem, but it has continued over the summer and recently it got worse."
Walgreens and Publix pharmacies confirm that they are experiencing some shortages in these drugs. Sometimes the drug is available, but not in the prescribed dose. For example, the shorter-acting drugs seem to be a bigger issue, Hughes said.
Adderall has been listed among those in shortage by the U.S. Food and Drug Administration off and on since 2009, said Erin Fox, who tracks the shortage data as manager of the drug information service at the University of Utah.
Then this month, the active ingredient in Ritalin and its generic counterparts, methylphenidate, joined the list.
The reasons for this shortage, like the reasons for the myriad of other drug shortages nationally, are difficult to pinpoint, Fox said. Companies cite increased demand, problems in distribution and tight Drug Enforcement Administration rules on how much of the active ingredient each maker can use in a given year.
"It's a very complex problem, and I have to tell you that I'm not seeing many easy answers," said Hughes, the ADHD advocacy group official.
Drug shortages have plagued the medical field for at least the past year, but most of the drugs in question have been intravenous ones used by hospitals or drugs that catered to a very specific illness, such as a brain cancer.
The population relying on these ADHD medications is vast, Hughes said. An entire generation of children with the disorder have grown up with the option to address their problems with these drugs.
They are, however, powerful drugs.
The DEA classifies them as Schedule II substances, which means they carry a "high potential for abuse" that "may lead to severe psychological or physical dependence." As such, the federal government sets limits on how much of these drugs can be manufactured each year.
Some might shrug at the situation - after all these are not life-saving cancer drugs that are in short supply - but Hughes would have them think again.
"It's not a shrug," she said. "If my teen goes out and is driving without his medication, the likelihood of him having a very serious car accident is three times higher than it was before."
For some teens, coping with ADHD in the long term without medication can contribute to alcohol or drug abuse, lead to criminal behavior and increased teen pregnancy rates, Hughes said, referring to more than a decade of research.
Younger children use these drugs to help keep them on task in school and to curb those impulses to act out at unexpected triggers.
But while children are more often prescribed drugs to cope with this disorder, there are at least 3.2 million adults taking these medicines to help them focus at work and at home, Hughes said.
Doctors and pharmacists are struggling to meet the demand.
Barry Paraizo, who owns Winships Prescription Center in North Palm Beach, says he also recalls having supply problems at the end of last year.
"You get patients bouncing around stores; they've tried Walgreens or CVS," Paraizo said. "But if I can't take care of my patients, I can't supply other pharmacies' patients.
"It gets frustrating," he said.

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What to do?
If you experience difficulty in filling an ADHD prescription :

• Ask your pharmacist if the medication is available from another location, especially if you use a large chain pharmacy.
• Contact the manufacturer to help locate a pharmacy that has your medication in stock .
• Contact the doctor who prescribed the medication to request samples .
• Ask your pharmacist about the availability of other medications used to treat ADHD.
• As a last resort, discuss with your prescribing physician whether or not any of these available medications might be appropriate for you or your child.
• Finally, if you still can't get a prescription filled due to a medication shortage:

Tell the FDA: Send an email to drugshortages@fda.hhs.gov or call 888-INFOFDA or 888-463-6332 .
Tell CHADD: 800-233-4050 .

FDA commish outlines plan to speed new drug development

That blast from the NVCA today is just the latest example of the growing chorus of criticism from lobbyists and political opponents over the regulatory process faced by drug and device developers. The regulatory burden had grown too cumbersome and too uncertain, they claimed, which was threatening to throttle innovation and cost the country some much-needed jobs. And yesterday FDA Commissioner Margaret Hamburg outlined a plan intended to appease the critics.
Innovative new drugs targeted at serious unmet medical needs, she said, will be provided an "expedited drug development path." A new deputy FDA commissioner will be charged with overseeing the regulatory process for drugs, biologics and cell-based treatments. Personalized meds will be given a top priority. And the country's top biotech entrepreneurs will be sought out to offer insights on how the agency can do better.


"The Obama Administration is committed to encouraging the entrepreneurs and businesses that are modernizing and strengthening our health care system," said HHS Secretary Kathleen Sebelius. "The innovation blueprint is another part of our effort to help businesses grow and keep Americans healthy."
Will it prove enough to satisfy the critics? Some are taking a wait-and-see approach on whether the FDA can walk the talk.
"Many in the private sector-especially investors in medical technologies-say America is beginning to lose its competitive edge in this arena, as many innovative start-up companies are choosing to commercialize, and hence create jobs, overseas," notes Timothy Hay, who writes the Venture Capital Dispatch for the conservative Wall Street Journal. "One of the most oft-cited reasons for the phenomenon is the unpredictability at the FDA."

Venture Firms Reduce Biotechnology Investment on FDA Risk

Oct. 6 (Bloomberg) -- Venture capital firms are investing less in experimental drugmakers and medical device makers because of what they say are regulatory hurdles, a survey found.

Almost 40 percent of 150 venture capital firms that responded to the survey have decreased their investment in life sciences during the past three years, the National Venture Capital Association said today in a statement. The same proportion expect to continue to reduce their spending on these companies over the next three years, a potential $500 million loss, the association said.

“The process has gotten to be so long, and the capital required so deep, that it’s becoming more and more difficult to generate venture-type returns and therefore make it worth your while to do it,” said Terry McGuire, co-founder and general partner of Polaris Venture Partners and past chairman of the association, in an interview.

Venture firms have shifted their investments overseas, where McGuire says regulatory approvals come quicker. More than one-third of survey respondents said they would increase their spending in Europe and 44 percent in Asia, compared with 13 percent saying the same for North America.

The U.S. Food and Drug Administration is taking steps to address some of the industry’s concerns, Commissioner Margaret Hamburg said yesterday in a statement. The agency plans to streamline regulations and speed up the approval process for some drugs, among other changes.

The agency approved 25 new drugs as of Sept. 15 and at that pace, by year’s end, would clear the most new drugs in since 2004, according to Bloomberg data.

--With assistance from Anna Edney in Washington and Catherine Larkin in Indianapolis. Editors: Andrew Pollack, Donna Alvarado

Campbell med school takes step forward

The planned Campbell University    School of Osteopathic Medicine took a big step toward being accredited after the Commission on Osteopathic College Accreditation awarded it pre-accreditation status.
The need for more doctors has been well documented, and Campbell University leaders want to see their graduates fill the gap. http://www.bizjournals.com/triangle/print-edition/2011/07/15/campbells-med-school-aims-to-help.html
Gaining pre-accreditation status does not mean the school is fully accredited, of course, but is seen as a key step in that direction. The university will next seek provisional accreditation, awarded to schools that meet the standards for accreditation. Campbell hopes to achieve this status and begin recruiting students for the fall of 2013.
A ground-breaking ceremony for the 97,000-square-foot medical school facility will be held by early 2012. The school will be on U.S. 421 in Buies Creek about one-quarter mile from the main Campbell University campus. The medical school will cost more than $60 million for building construction, equipment and other startup requirements.
Nationally, enrollment in osteopathic medical colleges has grown to 20,600, a 6.5 percent increase from 2010, according to the American Association Of Colleges Of Osteopathic Medicine. More than 20 percent of new U.S. medical students are attending osteopathic medical schools, the association reports, a number it expects to grow.
Graduates from osteopathic medical colleges receive a DO degree, not an MD degree as from traditional medical colleges like the University of North Carolina at Chapel Hill or Duke University. Physicians with DO degrees have all the same latitude as those with MD degrees.

AdverseEvents: Why Big Pharma Is Scared Of This Startup

By taking lists of potential side effects out of the hands of the drug makers, the startup is letting people know what their pills might be doing to them in a more open way than big pharmaceutical companies ever have.

Last week during a Republican debate, as you may have heard, Michele Bachmann claimed that the HPV vaccine Gardasil can cause mental retardation. Prozac and other antidepressants are often linked to suicide. Ambien is rumored to cause amnesia in some patients. Which of these things are true? And how could we ever really know since the list of side effects that comes with medication never gives detailed statistics?
AdverseEvents, a California-based startup, is pushing the debate out into the open with a centralized database of how many side effects are happening from what drugs and what the patient outcomes are--and according to cofounder Brian Overstreet, "it scares the crap out of the pharmaceutical companies."
"The FDA has some of this [side effect] data, but it's unstructured, not searchable, and not standardized," explains Overstreet. AdverseEvent's proprietary algorithm, which took 18 months to build, takes into account data from the FDA, direct patient reporting, and even information from social media sites (AdverseEvents analysts are alerted to side effect discussions on patient discussion boards, for example, and try to extract data).
AdverseEvents also has an internal alert system, so that the company can track potentially dangerous side effects and alert the FDA if necessary.

The result: a clean, easy-to-read database for both health-care professionals and patients. Pictured above is the Prozac top 10 side effect list--and sure enough, suicide is on there. But Gardasil? Mental retardation isn't on the list, though the most common side effect is "drug exposure during pregnancy."
Pharmaceutical companies are, as you might imagine, not thrilled that AdverseEvents exists; they're used to controlling side effect information. "First they freak out about it, then they look in greater depth and say 'Wow, it's
really interesting and we could see how to use this but we're not ready.' And we explain that the data is coming--your customers are going to have it,
insurance companies and doctors are going to have it, and you need to be part of
the conversation," says Overstreet. Fast Company contacted Pfizer for comment, but we have not yet heard back.
AdverseEvents went live this month. It's free for patients, but the startup has a subscription based model for insurance companies, hospitals, and eventually pharmaceutical companies. AdverseEvents is also working on a mobile app.
"I think people are going to be horrified," says Overstreet. "That's the only reason I'm doing this--because it scares me a lot."