During Pregnancy, Majority Of B.C. Women Take Prescription Drugs

Main Category: Pregnancy / Obstetrics

Also Included In: Pharmacy / Pharmacist;  Anxiety / Stress;  Sleep / Sleep Disorders / Insomnia

Article Date: 20 Dec 2011 – 0:00 PST

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Almost two-thirds of women in British Columbia filled at least one prescription at some point in their pregnancy, including drugs with potential risks, according to a new study by University of British Columbia researchers.

The study, published online in the journal Clinical Therapeutics, is the first of its kind in Canada. Researchers analyzed population-based outpatient prescription claims data for patterns of prescription drug use during pregnancy in B.C. from 2001 to 2006.

The researchers found that 63.5 per cent of pregnant women in B.C. filled at least one prescription. One in thirteen – or 7.8 per cent – filled a prescription for a medicine known to be risky in pregnancy – most often for select medicines for anxiety, insomnia and depression. Drugs that are strictly contraindicated in pregnancy, however, were filled in less than 0.5% of pregnancies.

“Although much remains to be understood about the appropriateness of medicine use that actually occurs among pregnant women in B.C., one encouraging finding from our study is that existing use of medicines with known risks declines dramatically when women become pregnant,” says co-author Steve Morgan, an associate professor in the School of Population and Public Health (SPPH) and Associate Director of the Centre for Health Services and Policy Research (CHSPR).

On average, pregnant women filled 2.6 different types of drugs, while 15 per cent used five or more prescription medications during their pregnancy. Prescriptions most frequently filled during pregnancy were for antibiotics (30.5 per cent), respiratory drugs (25.7 per cent), dermatologics (13.4 per cent), and drugs that act on the nervous system (12.8 per cent).

Other study findings include:

  • The use of medicines in pregnancy slightly increased over time, going from 63 per cent of women in 2001 to 66 per cent in 2006.
  • Women aged 20 years or younger were most likely to take prescription drugs during pregnancy (69 per cent) while the lowest rate occurred among those aged 30 to 35 years (62 per cent).
  • Prescription medication use was also high in the first three months immediately following delivery, a period when women may be breastfeeding, with 61.3 per cent of women filling prescriptions.

“Since pregnant women are normally excluded from clinical trials of new drugs and post-market study is limited, there is little evidence on the risks and benefits of many of the most commonly used drugs in pregnancy,” says lead author Jamie Daw, a researcher at CHSPR, part of SPPH. “Given the prevalence of prescription drug use, more research is needed to help pregnant women and their physicians make informed decisions.”

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Experts Gather To Discuss The Efficient Creation And Delivery Of Nanoscale Particles Of Drugs

Main Category: Pharma Industry / Biotech Industry

Also Included In: Biology / Biochemistry

Article Date: 02 Dec 2011 – 0:00 PST

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From targeted cancer chemotherapy to the guarantee of successful organ transplants, the 21st century may prove to be the age of big ideas in medicine.

The drugs themselves, though, will be minuscule.

Experts in chemistry, applied physics, materials science, and pharmaceutical science gathered this week for the BASF Advanced Research Initiative at Harvard University’s symposium on pharmaceutical nanoformulations.

The two-day symposium, co-hosted by the Harvard School of Engineering and Applied Sciences (SEAS) and leading chemical company BASF, and held at the American Academy of Arts and Sciences in Cambridge, provided an opportunity for more than 200 leading researchers to discuss the challenges of modern medicine and the search for innovative solutions in nanotechnology.

Small particles with big potential

A great deal of research in engineering and the applied sciences today involves the manipulation of materials at the nanometer scale to achieve particular physical and chemical properties.

In the realm of pharmacy science, for instance, many recently developed drug compounds are strongly hydrophobic, meaning that their molecules do not dissolve easily in water – or, therefore, in the bloodstream.

“That problem can be overcome if the drug particles are tiny enough, on the order of a few billionths of a meter,” says David Weitz, Mallinckrodt Professor of Physics and Applied Physics at SEAS and co-director of the BASF Advanced Research Initiative.

The grand challenge in the field of nanoformulations involves both the creation of precisely tailored, nanoscale particles of drugs and the safe and efficient delivery of those tiny particles to their exact targets within the human body.

BASF supports researchers at SEAS and across Harvard who are exploring a variety of approaches to this problem.

“I have a vision that is inspired in part by the fact that most people say it’s impossible,” says Weitz. “I think we can make meaningful quantities of valuable materials using microfluidics as a fabrication strategy. There are people at BASF who believe in that, and they’ve been supporting work in my lab.”

At the symposium, he says, “I’ll try to convince people that yes, we can.”

Attendees will also hear from George Whitesides, Woodford L. and Ann A. Flowers University Professor at Harvard; and David Mooney, Robert P. Pinkas Family Professor of Bioengineering at SEAS. (Whitesides and Mooney are also core faculty members at the Wyss Institute for Biologically Inspired Engineering at Harvard.)

At SEAS, Mooney has been working to develop a therapeutic cancer vaccine that enhances the body’s immune response by using novel biomaterials and nanoparticles to deliver signals to the cells that initiate adaptive immunity.

(The full list of speakers is available here.)

Joining competencies: Industry meets academia

The BASF Advanced Research Initiative at Harvard University represents a powerful model for university-industry collaboration, providing direct funding to faculty, graduate students, and researchers at SEAS and across the University. Created in October 2007, the initiative fosters a vibrant and dynamic intellectual exchange and accelerates the adoption of significant new technologies.

“Innovations succeed best of all in collaboration with good partners,” says Jens Rieger, Senior Vice President, Polymer Research Division, BASF SE, and co-director of the BASF Advanced Research Initiative at Harvard. “Our research cooperation with Harvard has not only strengthened our research network in the United States, but provided an optimum basis for collectively harnessing the innovative potential of new technologies to confront global challenges. Together we have demonstrated that we have formed the right team to find sustainable solutions for enhanced quality of life.”

BASF supports research in nine different laboratories at Harvard, involving work in materials science, applied mathematics, applied physics, bioengineering, molecular and cellular biology, microbiology and immunobiology, and chemistry and chemical biology. Nanopharmaceuticals represent one thrust of the research; the other involves preventing or removing biofilms – a type of bacterial growth that can cause serious diseases in humans and are a major concern in industrial processes and water management.

BASF has provided Harvard with direct funding since 2007, supporting the careers of 22 graduate students and 32 postdoctoral researchers. The collaboration has led to a number of patents and publications.

“The partnership works because BASF is an organization that brings us really intellectually challenging problems, that incorporates our results into its business, that learns from us, and that supports our research,” says Weitz. “The value to them, in turn, is that we bring people who are a little bit removed from the day-to-day pressures of their business, but who can work together constructively to tackle difficult problems in a multidisciplinary way.

“This has become a model for interactions between industry and academia,” Weitz adds.

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Thousands Of Seniors Hospitalized Due To Diabetes Drugs And Blood Thinners Annually, USA

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Main Category: Seniors / Aging

Also Included In: Pharmacy / Pharmacist;  Blood / Hematology

Article Date: 27 Nov 2011 – 7:00 PST

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Diabetes drugs and blood thinners cause two-thirds of the 99,628 US senior hospitalizations each year because of drug adverse events, researchers from the CDC reported in NEJM (New England Journal of Medicine). The authors added that hundreds of millions of dollars could be saved if focus were placed on education and drug management of patients with certain long-term (chronic) diseases and conditions.

This article comes as the US government aims to bring down the number of repeat hospitalizations by one fifth by the end of 2013.

Dan Budnitz, M.D., M.P.H., director of CDC’s Medicaton Safety Program said:

“These data suggest that focusing safety initiatives on a few medicines that commonly cause serious, measurable harms can improve care for many older Americans. Blood thinners and diabetes medicines often require blood testing and dosing changes, but these are critical medicines for older adults with certain medical conditions.

Doctors and patients should continue to use these medications but remember to work together to safely manage them.”

According to Medilexicon’s medical dictionary:

An adverse event is “Any untoward medical occurrence that may present during treatment with a pharmaceutical product but which does not necessarily have a causal relationship with this treatment.” [International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.]“

Budnitz and team gathered information from 58 hospitals around the country between 2007 and 2009. They said their data came from a nationally representative sample; patients involved in the CDC’s National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance project. Their study did not include emergency hospital visits cause by drug abuse, withdrawal or deliberate self-harm.

48.1% of hospital admittances occurred among patients aged at least 80 years. 65.7% were caused by drug overdoses, or unexpected reactions to medications which were taken according to instructions.

Four medications, used either on their own or in combination, cause two-thirds of emergency hospitalizations:

  • Warfarin – caused 33% (33.171) of hospitalizations. Warfarin is a blood thinner – it prevents the formation of blood clots. When not monitored properly it can lead to hemorrhaging. The authors believe the cost of warfarin-cause hospitalizations is in the hundreds of millions of dollars annually.
  • Insulin injections – caused 14% of emergency hospitalizations. Insulin injections are used for blood sugar control in patients with diabetes.
  • Antiplatelet drugs – caused 13% of emergency hospitalization. Examples include aspirin and clopidogrel. These drugs also help prevent the formation of blood clots (prevent platelet formation)
  • Oral hypoglycemic agents (oral diabetes drugs) – caused 11% of emergency hospitalizations.

The authors say that national monitoring of adverse drug events of newly approved medications is vital, especially those that become popular.

The researchers noted that drugs which are currently viewed as high risk for hospitalizations, such as painkillers (acetaminophen), were not causing a very high number of hospitalizations of seniors.

Chief medical officer of the Centers for Medicare & Medicaid Services, Patrick Conway, M.D., M.Sc., said:

“Policies and improvement programs to promote safe use of medications that most commonly cause serious, measurable harms can increase patient safety and reduce unnecessary hospitalizations and costs at the same time.

We are working across the federal government to address common preventable adverse drug events through medication management, care transition programs, and other initiatives.”

An elderly person is seven times more likely to be admitted to hospital for an adverse drug event than a younger individual, the authors explained.

Americans are living longer, this means that seniors will represent a higher percentage of the country’s population, which also means there will be even more adverse drug events. 12.8% of the US population was aged at least 65 years in 2010, a total of 16,901,232 senior males and 22,571,696 senior females.

Approximately 40% of seniors take between five and nine medications, while 18% are on at least ten drugs, the authors found.

The researchers say that there should be closer liaison between hospitals and primary-care doctors (general practitioners), to make sure that drug use is monitored properly – this would significantly reduce emergency hospitalization numbers. Budnitz said that pharmacists should also become more closely involved.

In an Abstract in the same journal, the authors concluded:

“Improved management of antithrombotic and antidiabetic drugs has the potential to reduce hospitalizations for adverse drug events in older adults.”

Written by Christian Nordqvist

View drug information on Warfarin Sodium tablets.



Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

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Visit our seniors / aging section for the latest news on this subject.
“Emergency Hospitalizations for Adverse Drug Events in Older Americans”

Daniel S. Budnitz, M.D., M.P.H., Maribeth C. Lovegrove, M.P.H., Nadine Shehab, Pharm.D., M.P.H., and Chesley L. Richards, M.D., M.P.H.
N Engl J Med 2011; 365:2002-2012November 24, 2011
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Warfarin – hospitalized, happened to me

posted by James Robinson on 27 Nov 2011 at 7:47 am

I am on warfarin and have been hospitalized because of it. The likelihood is much, much smaller with good monitoring. I changed doctors – the second one taught me the importance of it. It is crucial to have a good doctor who explains things properly.

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Adverse!

posted by Jason on 27 Nov 2011 at 8:06 am

The expression “Adverse event,” caps it all. Looking carefully enough at each drug any senior may be taking would eventually expose harmful effects from ALL — not just a select few. Most all of these drugs treat symptoms, none are cures. Many were manufactured to treat one disease and then later to treat another disease. This in itself should caution any user as to the actual efficacy of such “wonder drugs.” The official “adverse event” is failure of most patients to have neglected their health in the first place. First and foremost YOU are responsible for your health — whether YOU live a healthy life style.

Once taking a handful of medications the best thing and the most difficult thing for most patients (the drug dependents) is to get moving physically, and to control what they put in their mouths. Instead, most cop out and do the simple and least effective thing — opening the bottles and popping pills into their over fed mouths.

Some of the most serious adverse effects of the drug cocktail you take once or twice a day are seldom mentioned. This is the side effects caused by most any drug — the one called drowsiness, lethargy, agitation, emotional turmoil, and increased appetite. Even though the drug companies have to report this with each ad they throw at you, they love this vicious circle they put you in.

You are effectively too engrossed with all of these side effects to exercise or use self control when stuffing your mouth full of carbs and fat. Yet, the fact remains…only YOU can make the best change. And that, my dear souls, is to get moving (no better time than right now) and use portion control at each of three meals.

Do this gradually, following a written down record with goals set for each week. Do these two things every day no matter how difficult and you will begin to see changes that no drug company is going to tell you about. Should you not heed this advice you will be fodder for more and more drugs that the drug companies will be pushing onto your doctor to write a script for you to fill. This makes the drug company billions, it makes a six figure salary for your doctor, and makes most pharmacists far richer than you or me, and makes most nurses and the hospitals they serve some of the biggest incomes in the country. Get moving, but before you do, consult with your doctor before starting any exercise regimen or changing or modifying your diet while taking prescribed drugs.

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another factor

posted by Richard Crespin on 27 Nov 2011 at 8:15 am

I have been diagnosed as a diabetic, however; I have discovered that my body puts out boocoo insulin, yet, my body does not know it is there, so I added chromimum picolinate to my regimen, in doing so it helps my body to recognize the existing insulin.
Sincerely
Richard.

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Be aware of drugs that potentiate diabetes

posted by Daniel Haszard on 27 Nov 2011 at 8:22 am

The use of powerful antipsychotic drugs has increased in children as young as three years old. Weight gain, increases in triglyceride levels and associated risks for diabetes and cardiovascular disease. The average weight gain (adults) over the 12 week study period was the highest for Zyprexa—17 pounds. You’d be hard pressed to gain that kind of weight sport-eating your way through the holidays.One in 145 adults died in clinical trials of those taking the antipsychotic drug Zyprexa.
This was Lilly’s #1 product $ 5 billion per year sales,moreover Lilly also make billions more on drugs that treat diabetes.

— Daniel Haszard

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I have been on Coumadin and warfarin for 13 years

posted by Chester A Pilcher on 27 Nov 2011 at 8:23 am

I have been on Coumadin and warfarin for 13 years after suffering multiple pulmonary infarctions. my dosage never varied more than +/-2.5mg a week. recently Express Scripts substituted a so-called generic Jantoven even though my prescription said “no substitutions”. The pharmacist insists the “no” means they can substitute generics. My PT’s have become very erratic. May God help us as these kinds of people make life threatening decisions under Obamacare.

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Nursing Homes don’t monitor

posted by Dan McCaffrey on 27 Nov 2011 at 8:26 am

Those in a nursing home have no say in their dosage. Many fight to refuse medications but are forced the dosages prescribed by doctors that never see their patients.

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Disgrace!

posted by Sergio Balcazar on 27 Nov 2011 at 8:35 am

Does getting old means getting all kind of diseases?
I don’t think so.
People like to live the “normal” life, eating, drinking, smoking, getting fat, and eventually getting the so called “degenerative diseases” that start piling up in their late 30′s or early 40′s.

When they reach their 60′s and have been trusting their doctors and their pills believing that they will take care of their ailments, they come to realize that they are already loaded with complications of the very diseases that they had taken “good” care of.

Now they need more pills with all the side effects that these carry.
That is why, about 14 years ago I decided to stop living the “normal life” and start practicing a Prime Time Life.
With the “normal” life” you eat the “normal” foods, drink the “normal” drinks, practice the “normal” activities and eventually you get the “normal” diseases, and will die the “normal” death.
My advise for those who are aging (45, 50 y.o. and older) is, learn about living a Prime Time Life, and living a Healthy Lifestyle.
That way you will not need pills to “treat” or to “manage” any condition.
What pills do is to perpetuate and complicate the very medical condition that they are supposed to treat.
SB-MD

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obamacare

posted by Rena on 27 Nov 2011 at 8:56 am

You are an idiot, why in the world do you think everyone shouldn’t have health care?

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Opinion

posted by Claude T.Jacquet on 27 Nov 2011 at 9:04 am

I agree 100/100, there is a very poor or no communication between Doctors and patients,especially old patients,some of them,instead of asking you to change your diet,they keep on giving you drugs that have very bad side effects.

It is a big waste,some of the patients,throw them in the garbage and are afraid to tell their Doctors that they are not taking them. Myself, I am a 70 years old diabetic patient from Haiti,I do some research and use my own good judgement,instead of throwing them in the garbage,I just don’t use the refills,I know my body more than the Doctors,we have to work together,I use the medications that are really needed,thank you…….Claude

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Diet – Not Insulin

posted by john thomas on 27 Nov 2011 at 9:12 am

Putting diabetics on a low carb diet would decrease the need for insultin. Yet we tell them to eat anything they like and then take their drugs. Surely, ignorant doctors and nutritionists bear the blame for forcing high carb/essentially high sugar diets on people with blood glucose regulation problems.

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Discovery Enables Design Of Drugs That Could Target Particular Nerve Cells

Main Category: Neurology / Neuroscience

Also Included In: Pharma Industry / Biotech Industry

Article Date: 13 Nov 2011 – 0:00 PST

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The future of drug design lies in developing therapies that can target specific cellular processes without causing adverse reactions in other areas of the nervous system. Scientists at the Universities of Bristol and Liege in Belgium have discovered how to design drugs to target specific areas of the brain.

The research, led by Professor Neil Marrion at Bristol’s School of Physiology and Pharmacology and published in Proceedings of National Academy of Sciences USA (PNAS), will enable the design of more effective drug compounds to enhance nerve activity in specific nerves.

The team has been working on a subtype of ion channel called SK channels. Ion channels are proteins that act as pores in a cell membrane and help control the excitability of nerves.

Rather like an electrical circuit, ion channels work by allowing the flow of ‘charged’ potassium, sodium and calcium ions to enter or exit cell membranes through a network of pores formed by the channels, a subtype of which is the SK channel family.

The researchers have been using a natural toxin found in bee venom, called apamin, known for its ability to block different types of SK channel. SK channels enable a flow of potassium ions in and out of nerve cells that controls activity. The researchers have taken advantage of apamin being able to block one subtype of SK channel better than the others, to identify how three subtype SK channels [SK1-3] can be selectively blocked.

Neil Marrion, Professor of Neuroscience at the University, said: “The problem with developing drugs to target cellular processes has been that many cell types distributed throughout the body might all have the same ion channels. SK channels are also distributed throughout the brain, but it is becoming obvious that these channels might be made of more than one type of SK channel subunit. It is likely that different nerves have SK channels made from different subunits. This would mean that developing a drug to block a channel made of only one SK channel protein will not be therapeutically useful, but knowing that the channels are comprised of multiple SK subunits will be the key.”

The study’s findings have identified how SK channels are blocked by apamin and other ligands. Importantly, it shows how channels are folded to allow a drug to bind. This will enable drugs to be designed to block those SK channels that are made of more than one type of SK channel subunit, to target the symptoms of dementia and depression more effectively.

Vincent Seutin, one co-author of the paper, said: “Our study also shows a difference in the way apamin and nonpeptidic (potentially a useful drug) ligands interact with the channel. This may have important implications in terms of drug design.”

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The Belgian Science Policy-funded research is part of a collaborative project between the University of Bristol and the University of Liège in Belgium.
University of Bristol
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‘New Paradigm’ In The Way Drugs Can Be Manufactured

Main Category: Vascular

Also Included In: Pharma Industry / Biotech Industry

Article Date: 31 Oct 2011 – 0:00 PDT
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Robert Linhardt is working to forever change the way some of the most widely used drugs in the world are manufactured. In the journal Science, he and his partner in the research, Jian Liu, have announced an important step toward making this a reality. The discovery appears in the journal Science in a paper titled “chemoenzymatic synthesis of homogeneous ultra-low molecular weight heparins.”

Linhardt, the Ann and John H. Broadbent Jr. ’59 Senior Constellation Professor of Biocatalysis and Metabolic Engineering at Rensselaer Polytechnic Institute, and Jian Liu, a professor in the Eshelman School of Pharmacy at the University of North Carolina at Chapel Hill, have discovered an entirely new process to manufacture ultra-low molecular weight heparin.

The research shows that the drug is identical in performance and safety to the current and successful anticoagulant fondaparinux, but is purer, faster, and less expensive to produce.

“This research represents an entirely new paradigm in drug manufacturing,” Linhardt said. “With this discovery, we have successfully demonstrated that replacing the current model of drug production with a chemoenzymatic approach can greatly reduce the cost of drug development and manufacturing, while also increasing drug performance and safety, and reduce the possibility of outside drug contamination. It is our hope that this is the first step in the adoption of this method for the manufacture of many other drugs.”

The new process uses chemicals and enzymes to reduce the number of steps in production of fondaparinux from approximately 50 steps down to just 10 to 12. In addition, it increases the yield from that process 500-fold compared to the current fondaparinux process, and could decrease the cost of manufacture by a similar amount, according to Linhardt.

Fondaparinux, which is sold as a name-brand drug and was also recently approved by the FDA as a generic drug, is a synthetic anticoagulant used to treat deep vein thrombosis, with over $ 500 million in annual sales. It is part of a much larger family of anticoagulant drugs known as heparins. But, unlike most heparin products, it is chemically synthesized from non-animal materials. All other heparin-based drugs currently on the market use materials from the intestines of pigs and lungs of cattle as source materials. Such animal materials are more likely to become contaminated, according to Linhardt.

“When we rely on animals, we open ourselves up for spreading viruses and prion diseases like mad cow disease through the use of these heparins,” Linhardt said. “And because most of the raw material is imported, we often can’t be sure of exactly what we are getting.”

But, fondaparinux is extremely costly to produce, according to Linhardt. “The process to produce the drug involves many steps to purify the material and creates tons and tons of hazardous waste to dispose of,” Linhardt said.

The new process developed by Linhardt and Liu greatly reduces the number of steps involved in the production of the drug. This reduces the amount of waste produced and the overall cost of producing the drug.

“Cost should no longer be a major factor in the use or production of this drug,” Linhardt said.

The process uses sugars and enzymes that are identical to those found in the human body to build the drug piece by piece. The backbone of the material is first built sugar by sugar and then decorated with sulfate groups through the use of enzymes to control its structure and function in the body.

Linhardt and Liu have already begun testing the drug in animal models with successful results and think the drug could be quickly transferred to the market.

“Because the new drug is biologically identical in its performance to the already approved fondaparinux, the approval process for this new drug should work very similar to the approval process used for fondaparinux,” Linhardt said. He also thinks that this combined chemical and enzymatic synthesis can be quickly brought to patients in need and adapted for the production of many other improved carbohydrate-containing drugs.

“During this study, we were able to quickly build multiple doses in a simple laboratory setting and feel that this is something than can be quickly and easy commercialized to reduce the cost of this drug and help to shift how pharmaceutical companies approach the synthesis of carbohydrate-containing drugs.”

The finding is part of a much larger body of work occurring in the Linhardt lab to completely replace all types of heparin-based or other glycoprotein-based drugs with safer, low-cost, synthetic versions that do not rely on foreign, potentially contaminated animal sources.

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The research is funded by the National Institutes of Health.

Linhardt and Liu were joined in the research by Yongmei Xu, Haoming Xu, Renpeng Liu, and Juliana Jing of the University of North Carolina, Chapel Hill; Sayaka Masuko of Rensselaer Polytechnic Institute; and Majde Takieddin and Shaker Mousa of the Albany College of Pharmacy and Health Sciences.
Rensselaer Polytechnic Institute
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Following Canada’s Common Drug Review Fewer Drugs Listed On Public Drug Plans But Faster Listing For Coverage

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Main Category: Pharmacy / Pharmacist

Article Date: 26 Oct 2011 – 10:00 PDT
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A new study published in CMAJ discovered that, since the 2003 introduction of Canada’s Common Drug Review, the number of drugs covered by public drug plans has considerably decreased.

There are 19 public drug plans in Canada. In 2010, these plans accounted for approximately 39% of the projected $ 31 billion in drug-related costs. The plans include the costs of a variety of drugs prescribed to individuals. Prior to 2003, each of the 19 plans independently analyzed evidence and cost-effectiveness for novel medications that were considered for being listed in the plans. The Canada Common Drug Review, managed by the Canadian Agency for Drugs and Technologies in Health, was launched in order to standardize the process, improve effectiveness by grouping resources and expertise as well as to terminate duplication. Quebec does not participate in the Common Drug Review.

Investigators from the University of Alberta discovered that the amount of drugs listed for coverage decreased considerably. Drug plans who participated in the study, listed between 47% and 66% of novel medications in the five years prior to the introduction of the Common Drug Review and between 12% and 40% in the five years after. In addition, they discovered that the time from being recommended for listing to actual listed date varied between 99 to 358 days, in comparison with a mean time-to-listing of 778 days (over 2 years), prior to the Common Drug Review.

Furthermore, they found that listing decisions of public drug plans and recommendations of the Common Drug Review varied significantly.

Dr. Dean Eurich, School of Public Health, University of Alberta, and team, explained:

“The proportion of drugs listed decreased significantly after the introduction of the Common Drug Review for all participating drug plans included in our analysis. Time-to-listing decreased for a number of the smaller provinces.”

According to the researchers numerous factors may explain the decrease, such as uncertainty regarding how effective the medications submitted by pharmaceutical companies for review are in clinical trials.

They state:

“Our findings suggest that the Common Drug Review may have contributed to a streamlining of the process for reviewing drugs for certain jurisdictions. Specifically, patients in the provinces of New Brunswick, Prince Edward Island, and Newfoundland and Labrador may have benefited with earlier access to new drugs. Any substantial gains in savings or in the efficiency of publicly funded drug plans to make listing decisions are important factors in maintaining the health and safety of Canadian patients.”

Written by Grace Rattue
Copyright: Medical News Today
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”Analysis of drug coverage before and after the implementation of Canada’s Common Drug Review”

John-Michael Gamble et al.
CMAJ, October 24, 2011, doi: 10.1503/cmaj.110670
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Grace Rattue. “Following Canada’s Common Drug Review Fewer Drugs Listed On Public Drug Plans But Faster Listing For Coverage.” Medical News Today. MediLexicon, Intl., 26 Oct. 2011. Web.
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Grace Rattue. (2011, October 26). “Following Canada’s Common Drug Review Fewer Drugs Listed On Public Drug Plans But Faster Listing For Coverage.” Medical News Today. Retrieved from
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Fake And Substandard Drugs Entering Legitimate US Supply Chain, Authorities Warn

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Main Category: Regulatory Affairs / Drug Approvals

Also Included In: Public Health;  Pharmacy / Pharmacist

Article Date: 29 Sep 2011 – 11:00 PDT
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A preliminary report warns of potentially serious threats to the legitimate US drug supply chain of counterfeit and substandard drugs, say the FDA (Food and Drug Administration), NABP (National Association of Boards of Pharmacy) and some pharmaceutical companies. The FDA warns of serious risks and vulnerabilities in the drug supply chain in the USA.

The FDA wrote yesterday:

“Review revealed various schemes and examples of the types of players in the supply chain, how different products enter the supply chain, and how fraudulent or diverted products were discovered. Having a better understanding of these characteristics will help [FDA] to identify potential vulnerabilities.”

The FDA report, titled “Preliminary Review of Agency’s Diversion and Counterfeit Criminal Case Information”, gives examples, including:

  • Products being stopped at the border
  • Some diversion schemes specifically aimed at the system’s vulnerabilities to the supply chain
  • Involvement of unscrupulous wholesale distributors
  • One example of a diversion scheme in which a pharmacists and a pharmacist sold diverted drug samples

The FDA says that its report is a preliminary one, of..:

“..OCI case information and does not contain statistical inferences, future trend predictions or opinions. FDA expects to conduct further analysis and report as appropriate.”

In its report, the FDA claims the USA, with its strict regulatory framework governing medication distribution and production, has one of the safest legitimate drug distribution systems worldwide. It adds, however, that the Agency is concerned about the country’s drug supply and its growing vulnerability to a range of illegal activities that could seriously undermine public health if they are not addressed properly and promptly. Illegal activities range from making fake drugs to the stealing of legitimate medications.

If legitimate drugs are diverted, it is no longer possible to guarantee their safety and efficacy when they re-enter the legitimate supply chain. Counterfeit drugs, many with no proper active ingredients, inappropriate dosages, and sometimes potentially harmful ingredients, also have the potential to seriously impact on public health.

The following factors have forced the FDA to re-evaluate its approach to global supply-chain safety:

  • Complex international supply chains
  • Regulated products being sourced and manufactured abroad
  • The increased volume of imported products
  • The increased complexity of imported products

In order to protect public health, the FDA urgently needs to find ways to tighten up security of the drug supply chain for its consuming citizens. The FDA stresses that intentional acts to illegally take advantage of the drug supply chain can occur anywhere in the drug life cycle, from its manufacture through to final distribution. The adulteration, diversion or counterfeiting of pharmaceutical ingredients to inactive “excipients” are real current threats.

Even though drug counterfeiting is rare in the US drug distribution system, it has been a progressively growing problem over the last decade. Drugs are being produced illegally – either with inactive or harmful ingredients, they are being stolen, and replaced with lower dosages or cheaper illegally-produced alternatives. The FDA adds that criminals involved in these activities are becoming more sophisticated in their movements. The Agency gives the examples of diethylene glycol for glycerin in elixirs, and the use of allergenic compounds in heparin.

Some experts and patients groups comment that the USA, with the most expensive prescription drugs in the world, is logically going to have groups trying to offer cheaper alternatives. In a country where millions of people cannot afford to fill their prescriptions, under the current system demand for such products will remain large.

Written by Christian Nordqvist
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Christian Nordqvist. “Fake And Substandard Drugs Entering Legitimate US Supply Chain, Authorities Warn.” Medical News Today. MediLexicon, Intl., 29 Sep. 2011. Web.
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Christian Nordqvist. (2011, September 29). “Fake And Substandard Drugs Entering Legitimate US Supply Chain, Authorities Warn.” Medical News Today. Retrieved from
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When To Administer Food And Drugs Together

Main Category: Cancer / Oncology

Also Included In: Pharmacy / Pharmacist;  Breast Cancer;  Prostate / Prostate Cancer

Article Date: 20 Sep 2011 – 3:00 PDT
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A regulatory bias against taking oral anti-cancer medications with food places many patients at increased risk for an overdose and forces them to “flush costly medicines down the toilet,” argues Mark Ratain, MD, an authority on cancer-drug dosing.

In a commentary published early online Sept. 19 in the Journal of Clinical Oncology, Ratain, the Leon O. Jacobson professor of medicine and director of the Center for Personalized Therapeutics at the University of Chicago Medical Center, says it could be safer, more effective and more cost-efficient if the many cancer drugs that are better absorbed with food were studied and, when appropriate, prescribed to be taken with food.

“Instead of taking high doses on a empty stomach – which is how most of these drugs are labeled – patients would be better off taking much lower doses along with a meal,” Ratain said. “This could reduce the risks of an overdose, save money and give patients more control over their daily lives.”

In the last two decades, drug treatment for cancer has shifted away from drugs given through an intravenous line to drugs taken by mouth. Drug makers have set dose levels for these drugs based on data from patients who take their pills on an empty stomach. But many drugs are absorbed much more effectively with food, especially with a high-fat meal.

“With a monthly outlay measured in thousands of dollars,” Ratain said, “we should view drug-drug or drug-food interactions as opportunities to lower costs.”

Abiraterone acetate (ZYTIGA), approved April 28, 2011, for the treatment of metastatic prostate cancer, is a perfect example. It has a “food effect” greater than any other marketed drug. The dose can increase fivefold with a low-fat meal and tenfold with a high-fat meal. Patients are instructed to take it while fasting.

“No food should be consumed for at least two hours before the dose of ZYTIGA is taken and for at least one hour after the dose of ZYTIGA is taken,” warns the package insert. “The tablets should be swallowed whole with water.”

“Taking this drug according to instructions means the amount of the drug available to fight cancer is decreased by 80 to 90 percent,” Ratain points out. “At least three-quarters of it, at a per-patient cost of about $ 5,000 a month, is literally wasted. It gets excreted and flushed away.”

More worrisome is the risk of an overdose if a patient takes the standard dose – 1,000 mg daily – after fasting for two hours, then gets hungry and, rather than fast for one more hour, eats a meal. Depending on the caloric intake, he could get up to 10 times the intended dose.

Instead, offers Ratain, patients could take one-fourth of the dose with a healthy, low-fat breakfast. They could get the same anti-cancer benefit, eat when they are hungry and save an estimated $ 3,750 per month. “This way, the patient gets a simplified schedule, the convenience of eating whenever he wants, and shares the savings with his the insurance company.”

Patients should “never launch such experiments on their own,” he cautions. Physicians should assess the effects, note person-to-person variations, and learn to predict how individual patients will take up and metabolize such drugs in the presence of certain foods.

Another drug with a similar food boost is lapatinib (TYKERB), used to treat breast cancer. A meal increases the bioavailability of the drug by 167 percent; a high-fat meal increases uptake by 325 percent.

Although the food effect is smaller than for abiraterone, “we could potentially use 40 percent of the drug and save each patient about $ 1,740 a month,” Ratain said. The major toxicity associated with the drug is diarrhea, which may be caused by unabsorbed drug. So “taking a lower dose with food should increase absorption and potentially reduce this side effect.”

A third example is nilotinib (Tasigna) capsules, approved in 2007 for treatment of chronic myeloid leukemia. Patients take nilotinib twice a day on a stomach that has been empty for two hours and must remain empty for another hour. Because elevated nilotinib levels can cause heart-rhythm irregularities and sudden death, the no-food alert appears 11 times in the package insert. Two of those alerts are “black-box” warnings, which is “the industry’s way of saying ‘if you take this drug with food you might die,’ ” Ratain said.

For drugs whose absorption is decreased when taken with food, the FDA generally advises taking the pills while fasting. For non-cancer drugs where uptake is enhanced by food, the FDA favors taking them with a meal.

Yet for oral anti-cancer drugs, the FDA appears to have “an apparent bias for fasting,” Ratain said. “That is inconsistent with labeling in other therapeutic areas, and with fundamental principles of clinical pharmacology.”

View drug information on Tasigna; Tykerb; Zytiga.
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Is It Possible To Rank Different Drugs By The Harm They Cause? Revisiting The David Nutt Debate

Main Category: Pharmacy / Pharmacist

Article Date: 08 Sep 2011 – 0:00 PDT
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The scientific and political worlds were transfixed in late 2009 when UK drugs advisor Dr. David Nutt was sacked by Home Secretary Alan Johnson for his controversial views on the harmfulness of different drugs and the lack of evidence behind current drug policy, views first publicised in a Lancet report in 2007.1 Scientists at the time were unanimous that scholarly research such as Nutt’s should not be subject to political attack, but a new article in the scholarly journal Addiction points out a more rational basis for criticizing Nutt’s work on the harmfulness of drugs: it is scientifically flawed.

American researchers Jonathan Caulkins, Peter Reuter, and Carolyn Coulson argue that Nutt erred by assuming that drug-related harms can be reduced to a single dimension. Most such rankings combine individual harms and harms to society. But national drug policies aim to reduce harm to society, so combined scores may be misleading. Furthermore, it is not for scientists alone to decide the relative weights society should place on such disparate drug-related harms as dependence, overdose death, and corruption. Caulkins and colleagues also argue that even perfect ratings of substances’ current harm to society would not be useful, because harm is governed by the interaction between substance and policy; it is not a property of the chemical alone. Policymakers need analytical tools that show the likely changes in different types of harm associated with each change in drug policy.

Addiction hosts a spirited international debate about these critiques, including a response from Dr. Nutt himself.

Canadian researchers Benedikt Fischer and Perry Kendall argue that there is no benefit to categorically knocking down the work of Nutt and his colleagues when current global drug control policy pays scientific evidence no heed. The primary problem at hand is to get governments to pay attention to the evidence for drug policies, not to develop more complex rankings that will be ignored. Fischer and Kendall state, “If we assume public health and welfare should be guiding principles for substance control policy, we would not expect to see the third most commonly used drug (cannabis) to be scheduled and regulated alongside drugs like heroin and cocaine, while alcohol and tobacco are not only legally available, but are openly traded and lead to thousands of cases of deaths and injuries each year.”

This view is supported by Norwegian researcher Ingeborg Rossow. She argues that Norwegian policymakers’ views reflect those of the general public: illegal substances constitute a larger problem than alcohol, which justifies strict control of illegal drugs and liberalization of alcohol control. Addiction researchers know that legal substances (alcohol, tobacco, prescription drugs) are as much a problem as illegal substances, but getting the public to recognize this fact is difficult. Publicising reports on the relative size of harms from legal and illegal substances may help to change public opinion.

Australian researcher Robin Room argues that all national drug schedules are based on two outdated, pharmacologically-based international drug treaties from 1961 and 1971. By ranking drugs in the light of changes in knowledge and understanding since then, Nutt and colleagues have “started a debate which is long overdue.”

“The priority of the debate” Room argues, “should be on the official schedules and what to do about them.”

Isidore Obot, a Nigerian researcher, embraces the idea of developing more complex policy tools, because more refined ranking systems will produce more useful information for policymakers. The value of the model developed by Nutt and colleagues lies in the improvements future researchers will make to it.

David Nutt’s defence is expressed in his Voltairian title, “Let not the best be the enemy of the good.” Nutt accepts that the 2007 harm-ranking model is imperfect but argues that it is nonetheless a good attempt to use scientific evidence in drug policy. Says Nutt: “we have provided the best currently available analysis of an extremely complex multifaceted data set. It ain’t perfect but is nevertheless good enough to be useful.” Nutt also explains that his simplified look at drug harms provides policymakers with a tool of the type they use: “All decisions regarding drug classifications resolve harms into a single scale point for each drug, so people, particularly politicians, are used to making and working with such estimations.”

Caulkins, Reuter, and Coulson respond by restating that the current methods of ranking drugs by harm are conceptually and methodologically unsound. Defending them on the grounds that that simplification is required is equally unsound. We need better methods for understanding the complex network of individual and aggregate harms. “[If] the public has trouble grasping multi-dimensional scales, that should be seen as a hurdle to overcome, not a restraint that needs to be accepted.”

The final word should perhaps go to Fischer and Kendall, who argue that any country that uses these admittedly flawed and limited harm scales to inform public policy will experience a “quantum leap of progress” toward evidence-based drug policy. They state that “The benefits from grounding drug control policy in Nutt et al.’s harm scales could be expected to be tangible and last until well after their critics have revised and improved them.”

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(1) Nutt D., King L.A., Saulsbury C., and Blakemore C. Development of a rational scale to assess the harm of drugs of potential misuse. Lancet 2007;369:1047-53.
Wiley-Blackwell
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The Future Of Drugs Is All In The Family

Main Category: Pharma Industry / Biotech Industry

Article Date: 07 Sep 2011 – 0:00 PDT
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In a first-ever comprehensive study of the species origins of nature-derived drugs, it is shown that drug-producing species are concentrated and clustered in a limited number of families, refuting the conventional view that as every nature species produces biologically active molecules, one can find drugs from almost any major block of species groups if one looks for them hard enough.

Whether you have a mild headache or you are running a fever, there is a high chance that the drug that is used to treat you comes from nature. Today, about half of the drugs on the market were discovered by screening collections of small molecules made by bacteria, fungi, snails, leeches and other such species.

In Singapore, the top selling drugs for treating common ailments that are derived from nature include No. 12 Aspirin (for pain, fever and inflammation), No. 2 Amoxil (antibiotic), No. 7 Procodin (for cough), No. 8 Beserol (muscle relaxant) and No. 3 Ventolin (for asthma and chronic obstructive pulmonary disease).

Worldwide, eight of the top 20 selling drugs available today are derived from nature, some of which include No. 2 Lipitor and No. 9 Crestor (both for treating cholesterol), No. 4 Advair Diskus (for asthma), No. 15 Lantus (for diabetes), and No. 18 Diovan (for hypertension).

Another six of the top 20 selling drugs in the world are mimics of natural products. No. 6 Abilify (for psychosis and depression), No. 7 Singulair (for asthma), No. 10 Cymbalta (for depression and anxiety disorders) are some of the examples.

Although the pharmaceutical industry has made serious efforts to get away from relying on the natural world by attempting to create rationally designed drugs using synthetic compounds, nature-derived drugs still constitute a substantial percentage (26%) of recently approved drugs.

Nature-derived drugs not in every species

The conventional view about nature-derived drugs is that as every nature species produces biologically active molecules, one can find drugs from almost any major block of species groups if one looks and searches for them hard enough.

This view has been proven wrong in a first-ever comprehensive study of the species origins of nature-derive drugs conducted by researchers from the National University of Singapore (NUS) and Tsinghua University. Published in Proceedings of the National Academy of Sciences of the United States of America in July 2011, the research showed that drug producing species are concentrated and clustered in a limited number of families.

Data analysed by the research team showed that out of 886 nature-derived drugs discovered in the last 50 years (1961 to 2010), 88% or 783 were from previously known drug producing families. A further 41 were from near neighbours of known productive families. Only 62 came from ‘dark horses’ that were completely outside of the known clusters.

Lead researcher Professor Chen Yu Zong from the Department of Pharmacy at NUS, said, “In each kingdom of life, the drug-producing families are strongly clustered. Only a limited number of molecular scaffolds are privileged drug-like structure made by specific metabolic genes in certain species families. Some families with lots of bioactive compounds have never produced a drug because their metabolic genes are not capable of producing privileged drug-like structures, even though they can produce bioactive structures. “

Focus on family members

The findings from this research can now point us to the direction on where to concentrate on the search for new drugs, and that is from pre-existing drug-productive families.

In explaining this rationale, Prof Chen said, “We have identified and highlighted a number of families that have not produced an approved drug but are likely in the drug-producing clusters and potentially produce future approved drugs. Just like by knowing the clustered distribution patterns of oil fields, one knows where to place their bets on the next oil field based on existing findings. For instance, if one finds the first oil-producing well somewhere in the South China seas, by knowing that oil fields tend to be clustered, there is a higher chance in finding the next oil fields by a search of the surrounding areas.”

By focusing on pre-existing drug-productive families, resources can be concentrated on manipulating and expanding the families for producing new, as well as existing drugs. In addition, these pre-existing drug-productive families can be studied on why they produce privileged drug-like structures, and the knowledge can be used for designing new and novel drugs.

The potential impact of the research, concludes Prof Chen, is “to promote bioprospecting efforts on those species and species families that are likely to produce new drugs, thus enabling the increase of new drug productivity.”

View drug information on Abilify; Amoxil; Crestor.
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