Compounding the Problem?

Here’s a question to get you thinking this Friday morning.  What has been called the “worst public health crisis” in the US in decades?  Is it:

(a)  HIV

(b)  Obesity

(c)  Healthcare.gov

(d)  Heart Disease

(e)  None of the above

While there’s no doubt options (a) through (d) challenge our healthcare system, the correct answer is in fact (e). What’s more, this public health crisis may have gone unnoticed by many. What we’re referring to is the fungal meningitis outbreak that was traced to the New England Compounding Center. So far, there have 751 reported cases, including 64 deaths.

Indeed, most Americans had never heard of compounding pharmacies until the now-shuttered New England Compounding Center was blamed for making tainted steroid injections that killed and sickened people in 20 states.

Since then, the FDA has issued more than 60 reports of compounding pharmacies that had one or more quality or sterility issues. Five compounding pharmacy testing labs received similar reports.

Now, after months of negotiating, the US Senate has finally passed legislation that was drafted in the wake of the scandal.  The Drug Quality and Security Bill will give the FDA greater oversight of compounding pharmacies and also creates a national system for tracking prescription medicines from factory to pharmacy. The bill, which was already passed by the US House, is designed to bolster the pharmaceutical supply chain, and now goes to President Obama for his signature

The bill will create a new class of compounding pharmacies, as suggested by the FDA. The agency believes that traditional compounders – those who mix or alter ingredients for individual patients on an as-needed basis, should be distinguished from ‘non-traditional’ compounders – those that sell high volumes and ship out of state because these activities may pose a higher risk.

“We know more from a barcode on a gallon of milk than we do from a barcode on a bottle of prescription drugs, which could mean the difference between life and death,” says US Senator Michael Bennet. “Whether it’s a stronger drug supply chain or better oversight for compounded drugs, this commonsense bill will help restore confidence in our prescription drugs and protect our families from potential health risks.”

The bill also creates a voluntary category for so-called office compounding of sterile medications. These operations would voluntarily register with the FDA and submit to GMP, or good manufacturing practices, compliance and pay fees in exchange for the right to ship product without a prescription. But there is no criteria concerning interstate shipping or the percentage of production involved.

The legislation “leaves regulation of this vital and long-accepted practice by independent community pharmacies to state boards of pharmacy, where it should be,” says the National Community Pharmacists Association.

But not everyone agrees.

Rosa DeLauro, a Democratic Congresswoman from Connecticut, says the “voluntary approach will continue to expose patients to potentially unsafe, mass-produced compounded drugs that are not approved or evaluated by the FDA.”

Similarly, the International Academy of Compounding Pharmacists released a statement saying that “a voluntary category of outsourcing facilities is not the answer” and warned that another potentially deadly New England Compounding Center type of scandal could still occur.

Some health policy experts have even said they fear the new bill will make drugs, less, rather than more, safe.

Critics say that by giving compounding pharmacies the option whether or not to register with the Food and Drug Administration and adhere to stricter guidelines for testing, quality and sterility, does not go far enough.

“It makes what is now illegal legal,” said Dr. Michael Carome, who directs the health research group at Public Citizen, a think tank.

Carome said he opposes the bill because it allows large scale compounding without individual prescriptions and with no requirement to follow the strictest quality and sterility guidelines that drug manufacturers must adhere to.

“It makes no sense to have two different tiers of drug manufacturers – one that has to meet all the manufacturing guidelines and one that only has to meet some of them. We believe in a level playing field.”

What do you think of this legislation?  Has it gone far enough?  We’d love to hear from you.

Birds do it. Bees do it. Even butterflies and chimpanzees do it.

SRxA’s Word on Health was intrigued by a story we read this week in National Geographic.

It seems we could have a lot to learn from the abovementioned animals.  It turns out that they, and many other species self-medicate, using plants and other surprising materials to improve not only their own health but also the health of their offspring.

A video of capuchin monkeys at the Edinburgh Zoo shows them rubbing onions and limes on their skin and into their fur as an antiseptic and insect repellent.

Biologists have noticed that parasite-infected female monarch butterflies are more likely to lay their eggs on anti-parasitic milkweed, giving their offspring instant medication, while uninfected females show no preference. And urban birds who incorporate cigarette butts into their nests may be doing so because chemical properties in the smoked cigarettes may repel parasites, according to a 2012 study.

While cigarette-butt wallpaper may not appeal to most of us, other ways that animals self-medicate might be worth watching.

Mark Hunter, a University of Michigan ecologist who was involved in the monarch research, says there is plenty to be learned from observing the way animals use the entire outdoors like one big drugstore. It’s something our own species probably once did – and might do well to revisit with modern pharmaceutical engineering and computer modeling techniques.

“It’s not the only way, but it seems to me that a sensible way would be to watch what animals do in nature to see how they exploit the natural products, the pharmaceuticals that are available to them in the environment, and try to learn from them,” he says.

Earlier this year, Hunter spent time with people of the Shangaan tribe in South Africa.

“If you go for a walk with somebody, every plant you pass has a cultural or medicinal significance, and many of those have been learned from watching animals,” Hunter says. The bark of the black monkey thorn tree, for example, is used as a stomach medication, a choice based on watching how elephants behave.

Not long ago primates were thought to be the only animals smart enough to self-medicate. But now we’re learning that ground squirrels chew rattlesnake skins and then lick their fur, a trick likely to deter that particular predator.

Insects have been found to be prolific self-medicators, too. Take the arresting case of the fruit fly Drosophilia melanogaster, which uses alcohol to protect itself against parasitic wasps. The wasps lay their eggs in the fruit fly larvae; the developing wasp grubs will eventually eat the flies from the inside out and burst forth from their dead bodies. Larvae that consume high doses of alcohol from fermented fruits, however, are less likely to be infected—and if they are, the invading wasp grubs die quite nastily with their internal organs being ejected out of their anus.

Moreover, fruit fly mothers who see female parasite wasps nearby will give their young instant protection by laying their eggs in alcohol-soaked environments – which means they see and remember their nemesis.

“Not a bad defense,” says Hunter, adding that this demonstrates the idea that “the cost we’re willing to pay for a medicine depends on the consequences of not using it.” While the alcohol isn’t necessarily good for the flies, they will die if parasitized.

“The alcohol has worse effects on the parasites than it does on them. So it’s worth laying your eggs in a high-alcohol environment if it will save your offspring,” he says.

Do animals learn to self-medicate, or is it pure instinct?

Well, plenty of intelligent animals self-medicate, so it’s not always clear. But in the case of the monarch butterfly the mothers don’t hang around to see what happens to their babies, so there’s no learning involved. In this case, the only possibility is that it’s a genetically determined behavior or instinct.

So the next time you’re on your way to the drugstore and pass a monarch hovering around a milkweed, or a bird who seems to have taken up a smoking habit, consider that they might actually be running an errand, just like you!

NSAID’s in the News (again)

Let me start by saying, that despite spending the last 20-something years in or around the pharmaceutical industry, I don’t like taking pills. That said, I’m not particularly partial to pain either. So when my knees or back hurts or I’m doubled over with dysmenorrhea, like many other people, I’ll reach for the ibuprofen.

But that may be about to change. Results from a new, large international study of non-steroidal anti-inflammatory drugs (NSAIDs), showed that high doses of them increase the risk of a major vascular event such as heart attack, stroke or death from cardiovascular disease by around a third.

In other words, for every 1,000 people with an average risk of heart disease who take high-dose ibuprofen for a year, about three extra would have an avoidable heart attack, of which one would be fatal, the researchers said.

This puts the heart risks of generic NSAIDs on a par with Vioxx – the painkiller that U.S. drugmaker Merck famously pulled from sale in 2004 because of links to heart risks.

The study team from Oxford University in the UK, gathered data, including on admissions to hospital, for cardiovascular or gastrointestinal disease, from all randomized trials that have previously tested NSAIDs.

This allowed them to pool results from 639 trials involving more than 300,000 people and re-analyze the data to establish the risks of NSAIDs in certain types of patients.

In contrast to the findings on ibuprofen and diclofenac, the study found that high doses of naproxen, another NSAID, did not appear to increase the risk of heart attacks. The researchers said this may be because naproxen also has protective effects that balance out any extra heart risks.

Researcher, Colin Baigent stressed that the risks are mainly relevant to people who suffer chronic pain, such as patients with arthritis who need to take high doses of for long periods. “A short course of lower dose tablets purchased without a prescription, for example, for a muscle sprain, is not likely to be hazardous,” he said.

He also warns patients not to make hasty decisions or change their treatment without consulting a doctor.

“For many arthritis patients, NSAIDs reduce joint pain and swelling effectively and help them to enjoy a reasonable quality of life,” he said. “We really must be careful about the way we present the risks of these drugs. They do have risks, but they also have benefits, and patients should be presented with all those bits of information and allowed to make choices for themselves.”

Donald Singer, a professor of clinical pharmacology and therapeutics at Warwick University, who was not involved in the study, said its findings “underscore a key point for patients and prescribers: powerful drugs may have serious harmful effects.”

In the meantime, I for one, will be revising my pain versus pill-popping habit, or switching to naproxen.

Born to have Baby Blues?

It’ s not clear what causes postpartum depression.  The condition, which is marked by persistent feelings of sadness, hopelessness, exhaustion and anxiety, usually begins within four weeks of giving birth and can persist for weeks, months or even up to a year. An estimated 10 to 18% of all new mothers develop the condition, and the rate rises to 30 to 35% among women with previously diagnosed mood disorders.

Scientists have long believed the symptoms were related to the large drop-off in the mother’s estrogen levels following childbirth, however studies have shown that both depressed and non-depressed women have similar estrogen levels.

Now researchers from Johns Hopkins say they have discovered alterations in two genes that, can reliably predict whether a woman will develop postpartum depression.

The genetic modifications, which alter the way genes function without changing the underlying DNA sequence, can apparently be detected in the blood of pregnant women during any trimester, potentially providing a simple way to foretell depression in the weeks after giving birth, and an opportunity to intervene before symptoms become debilitating.

By studying mice, the researchers suspected that estrogen induced genetic changes in cells of the hippocampus – the part of the brain that governs mood.  They  then created a complicated statistical model to find the candidate which could be potential predictors for postpartum depression. That process resulted in the identification of two genes, known as TTC9B and HP1BP3.

Little is known about these genes except for their involvement in hippocampal activity. However the team suspects that they may have something to do with the creation of new cells in the hippocampus and the ability of the brain to reorganize and adapt in the face of new environments. Both of these elements are known to be important in mood.

Furthermore, estrogen can behave like an antidepressant, so when it is inhibited, it adversely affects mood.

“Postpartum depression can be harmful to both mother and child,” says Zachary Kaminsky, Ph.D., an assistant professor of psychiatry and behavioral sciences at the Johns Hopkins University School of Medicine. “But we don’t have a reliable way to screen for the condition before it causes harm, and a test like this could be that way.”

The findings of the small study involving 52 pregnant women are described online in the journal Molecular Psychiatry.

The study involved looking for epigenetic changes tin the thousands of genes present in blood samples from 52 pregnant women with mood disorders. The women were followed both during and after pregnancy to see who developed postpartum depression.

The researchers noticed that women who developed postpartum depression exhibited stronger changes in those genes that are most responsive to estrogen, suggesting that these women are more sensitive to the hormone’s effects. Specifically, changes to the two genes – TTC9B and predicted with 85% certainty which women became ill.

“We were pretty surprised by how well the genes were correlated with postpartum depression,” Kaminsky says. “With more research, this could prove to be a powerful tool.”

Evidence suggests that early identification and treatment of postpartum depression can limit or prevent debilitating effects. Alerting women to the condition’s risk factors — as well as determining whether they have a previous history of the disorder, other mental illness and unusual stress — is key to preventing long-term problems.

Research also shows that postpartum depression not only affects the health and safety of the mother, but also her child’s mental, physical and behavioral health.

If the results of this preliminary work pan out then a blood test for the biomarkers could be added to the battery of tests women already undergo during pregnancy.  More importantly, the results could help to inform decisions about the use of antidepressants. While there are concerns about the effects of these drugs on the fetus and their use should be weighed against the potentially debilitating consequences to both the mother and child of forgoing them.

As Kaminsky says “If you knew you were likely to develop postpartum depression, your decisions about managing your care could be made more clearly.”

Cutting Costs by Cutting Pills

According to some disturbing data released yesterday by the CDC, many US adults aren’t following doctor’s orders. And it’s not just the very young or very old, who, it could be claimed,  don’t know any better.

It turns out that adults under the retirement age are twice as likely to skip their prescribed medications in order to save money to save money.

And although spending on drugs is expected to increase an average of 6.6% a year from 2015 through 202, 20% of adults regardless of age, have asked their doctors for a lower cost treatment.

Americans spent $45 billion out-of-pocket on retail prescription drugs in 2011. But, “if you’re not insured or you face high co-payments, you’re going to stretch your prescriptions,” says Steve Morgan, an associate professor at the University of British Columbia’s School of Population and Public Health in Vancouver. “Even among insured populations, there is this invincibility mindset among the very young. Older people are more likely to adhere to chronic therapies over a longer period of time than younger.”

The study also found that 13% of those ages 18 – 64 reported not taking their medications as prescribed to reduce costs compared with 5.8% of those 65 and older.

Strategies that alter the way adults take their medications include skipping doses and consuming less than the prescribed amount. About 11% of those aged 18 – 64 also delayed filling a prescription compared with 4.4% of those 65 and older.

Uninsured adults were more likely to have tried to stretch their medications than those with Medicaid or private insurance.

But are such savings worth it? Failing to take medication as prescribed may actually increase costs to the U.S. health system, particularly if medication non-adherence results in increased hospitalizations, or complications of chronic diseases.

Anytime a patient chooses not to take drugs as prescribed, the pharmaceutical industry pharma loses sales. A recent study estimated that pharma loses $564 billion globally to non-adherence to drugs. Not surprisingly then, the industry is experimenting with reminders, to increase adherence. Nevertheless, a nudge from a text or a talking pill container might not inspire patients who are penny pinching.

I’d love to stay and chat, but I need to run to the pharmacy to refill my blood pressure meds that I ran out of several days ago!

Emergency! Epinephrine in Anaphylaxis: under-use and inappropriate use by EMS

Despite a decline in anaphylaxis deaths over the past 25 years, lack of epinephrine and incorrect administration of epinephrine still play a significant role in mortality.

According to a retrospective case study by researchers from McMaster University in Hamilton, Ontario only a quarter of patients received epinephrine prior to cardiac arrest, including those treated by emergency medicine personnel.

Of the 80 deaths recorded in Ontario from 1986 – 2011, 47 had a known or suspected allergy to the fatal allergen, but only 18 had been prescribed an epinephrine auto-injector and only 9 had their auto-injector at the time of the reaction. And at least 8 of these people received epinephrine that was either expired or administered incorrectly.

“The low proportion of patients who received epinephrine correctly may indicate that more information is needed by both patients and first responders regarding indications and techniques for administering epinephrine and auto-injectors,” said lead investigator, Ya Sophia Xu, MD

Most of the fatalities were caused by food allergy (n = 37), insect sting (n = 27), or medication (n = 11).  But in 5 patients, death occurred with no known allergen.

More than half (59%) of the food-related fatalities involved food eaten away from home – at public places including school, camp, or another person’s home.

“Patients with food allergies should be especially vigilant when eating outside of the home,” added Dr. Xu “restaurants need to improve the labeling and disclosure of potential allergens to the public.”

The study also revealed that Coroners’ reports are sometimes lacking information about the severity of previous allergic reactions, level of asthma control, time of administration of the first epinephrine dose, body mass index of patients, and anatomical location of the epinephrine injection.

Ryan Jacobsen, MD, EMT who is associate emergency medical services director for the Kansas City Fire Department in Missouri commented “there seems a perception among pre-hospital personnel that the administration of epinephrine is dangerous.”  He and his colleagues recently published a study with very similar results.

Dr. Jacobsen’s team surveyed 3,500 nationally registered paramedics in the United States and found that 36.2% of responders felt there were contraindications to the administration of epinephrine for a patient in anaphylactic shock. And 40% of paramedics (incorrectly) believed that diphenhydramine was the first-line medication for a patient suffering from anaphylactic shock.

“They also had challenges in the recognition of atypical presentations of anaphylaxis and determining the correct location and route of epinephrine administration,” he said.

Only 2.9% correctly identified atypical presentation of anaphylaxis, while less than half (46.2%) identified epinephrine as the initial drug of choice. Equally concerning, only 38.9% correctly chose the intramuscular route of administration, while 60.6% incorrectly identified the deltoid, rather than the anterolateral thigh as the preferred injection site location.

As an EMS educator I spend much of my time, discussing the 5 Rights of Administration: right patient, right time, right drug, right route, right dose.

Yet, according to this study, it seems as if emergency medical personnel are routinely failing on all 5 when it comes to anaphylaxis.

“Basically, we have the same issues in the United States that were found in the Canadian study,” says Jacobsen. “There needs to be an aggressive educational campaign geared toward emergency personnel in both the safety of epinephrine and its importance as the first-line therapy for anaphylaxis.  The benefits of epinephrine almost always outweigh the risks, but there’s a reluctance to use it. Patients get palpitations, they might get a headache, their heart rate goes up, but it’s a potentially life-saving treatment.

Amen to that.

A Ray of Sunshine?

It’s already 15 months overdue and it will be another year still before the information is public, but last week  the government  set out  the final rule for the Physician Payment Sunshine Act (Sunshine Act) in a 287 page document!

The Sunshine Act (passed in 2010 as part of the Affordable Care Act) requires manufacturers of drugs, devices, biologicals, and medical supplies to report all payments and other transfers of value to physicians and teaching hospitals. The rule was supposed to be published in October 2011, but has suffered continuous delays amongst intense lobbying both by groups keen to get the data in the public hands, such as the AARP, and those most affected by it, such as the American Medical Association (AMA).

The final rule announced February 1^st, officially puts the Industry on notice. They have until March 2014 to get their payments reporting act together. The U.S. Centers for Medicare and Medicaid Services (CMS), will then input the data, including payment information from August through December of this year, into a publicly available database which, they say, will be online by September 2014.

And its not only payments to doctors of medicine that have to be reported. Under the definitions of the Act, “physicians” include doctors of osteopathy, dentists, podiatrists, optometrists and chiropractors.

The rule also requires reporting on both the form and nature of payment or transfer of value made by a manufacturer to a physician.

Forms of payment included under the final rule :

• Cash or a cash equivalent
• In-kind items or services
• Stock, a stock option, or any other ownership interest, dividend, profit or other return on investment
• Any other form of payment or transfer of value

While, nature of payments include:

• Consulting fees
• Compensation for services other than Consulting
• Honoraria
• Gifts
• Entertainment
• Food
• Travel
• Education
• Research
• Charitable contributions
• Royalty or license
• Current or prospective ownership or investment interest
• Direct compensation for serving as faculty or as a Speaker for a medical education program
• Grants
• Any other payment

Advocates of the Sunshine Act have long argued that the public needs to know when doctors are getting paid and by who. “You should know when your doctor has a financial relationship with the companies that manufacture or supply the medicines or medical devices you may need,” said Peter Budetti, M.D. CMS deputy administrator for Program Integrity. “Disclosure of these relationships allows patients to have more informed discussions with their doctors.”

This increased transparency is also intended to help reduce the potential for conflicts of interest that physicians or teaching hospitals could face as a result of their relationships with manufacturers.

Relationships between doctors and drugmakers have been brought up in a number of cases when FDA advisory panels have ruled for or against drugs in which doctors had some interest. For example, last year an advisory panel voted 15-11 to support the approval of Bayer‘s Yaz birth control pills, but allegations later surfaced that four committee members had ties to the manufacturer.

Once the bill is introduced, doctors will get 45 days after information is submitted to vet it for accuracy.

The American Medical Association (AMA) is not happy.  The doctors’ group wants physicians to have more than 45 days to challenge information in the government’s database and add commentary to explain the payments. It also wants some corporate contributions to physicians excluded from disclosure, including sponsorships for educational activities and “indirect” payments, such as unsolicited contributions a company might make to a nonprofit group affiliated with doctors or to physicians’ employers or practices.

AMA president Jeremy Lazarus wants to ensure “the registries will provide a meaningful and accurate picture of physician-industry interactions. It is critical that the final rule provide physicians with a clear way to correct any inaccurate information and not place any substantial administrative burden on physician practices.”

And the AMA is not alone. Unsurprisingly, the Pharmaceutical Research and Manufacturers of America (PhRMA), the primary lobbying group for drugmakers, said that while it supports more disclosure, the new regulations should take into account the importance of context in the publication of physician payment information.

“Ethical interactions between biopharmaceutical companies and health-care professionals are essential to maintaining patient trust,” said Matthew Bennett, a spokesman for PhRMA. The principle behind the so-called sunshine provision “is complementary to this belief and it has great potential for helping patients understand the ways in which such collaboration benefits their health and medical innovation,”

What’s your take on this new rule? Is the government helping to let the sun shine in or is this a dark, dark day for doctors and pharma?  Let us know your thoughts.

Fend off a 2nd Heart Attack with Fruit and Fiber

Each year, at least 20 million people worldwide survive a heart attack or stroke. Most of them, will then be prescribed a veritable cocktail of drugs including lipid-lowering agents, beta blockers, aspirin, anti-platelet medications, and angiotensin modulators.

In the misguided belief that this polypharmacy will guard against future catastrophic cardiovascular events, many patients think they don’t need to follow a healthy diet.

However a new, 5-year study of almost 32,000 patients in 40 countries showed those who ate a heart-healthy diet rich in fruits, vegetables and fish had an average:

• 35% reduction in risk for cardiovascular death
• 14% reduction in risk for new heart attacks
• 28% reduction in risk for congestive heart failure
• 19% reduction in risk for stroke

Researchers from McMaster University were able to demonstrate, for the first time, that while drug treatments, substantially lower the risk of another heart attack, a high quality diet also significantly lowers the risk.

Mahshid Dehghan, the study’s lead author and nutritionist at McMaster University’s Population Health Research Institute (PHRI) and his team assessed the association between diet quality and the risk of cardiovascular disease using information collected from men and women who participated in two major McMaster-led global studies: ONTARGET, and TRANSCEND.

Participants with cardiovascular disease were asked how often they consumed milk, vegetables, fruits, grains, fish, nuts, meat and poultry over the past 12 months. They were also asked about lifestyle choices such as alcohol consumption, smoking and exercise. A healthy diet was indicated by a high intake of fruits, vegetables, whole grains and nuts as well as a high intake of fish compared to meat, poultry and eggs.

The results showed that a heart-healthy diet offered a “consistent benefit” over and above the benefits of taking medications to reduce the risk of heart attack and stroke.

Globally, healthy eating was associated with a lower risk of cardiovascular disease by more than 20% in all regions of the world and across all income groups.

“Physicians should advise their high-risk patients to improve their diet and eat more vegetables, fruits, grains and fish,” Dehghan said. “This could substantially reduce cardiovascular recurrence beyond drug therapy alone and save lives globally.”

Doctors Deficient in Anaphylaxis Care

Having just returned from the American College of Allergy, Asthma and Immunology (ACAAI) annual meeting, we’re spoiled for choice of news. But among all the science there was one stand out shocker.  In a session on Sunday, physicians presented the results of a survey, sponsored by the Asthma and Allergy Foundation of America (AAFA). During this, they revealed that a disturbingly high proportion of primary care and emergency physicians don’t know how to treat anaphylaxis.

Interviews with 318 physicians indicated that:

• substantial numbers do not always provide epinephrine to patients – even those  they believe are having anaphylactic reactions
• they often fail to refer anaphylaxis patients for follow-up care
• they believe incorrectly that some patients should not receive epinephrine auto-injectors

Myron Zitt, MD, says the results reveal “likely deficiencies in physician knowledge,” and corroborate results from earlier chart review studies.

In the telephone-based survey, researchers conducted interviews lasting an average of 19 minutes with approximately 100 emergency room physicians, 100 allergists, 50 adult primary care physicians, and 50 pediatricians.

82% to 99% of respondents in each group said they had treated at least one anaphylaxis case.

Although epinephrine is supposed to be given to all patients having such reactions, about 10% of emergency room physicians and 20% of primary care and pediatric physicians said they had done something else.  These “something else’s” included prescribed another drug, sending the patient to a hospital, or an “other” action.

Prescribing of auto-injectors for patients to take home also was far from universal. Barely 60% of emergency room physicians said they did. In fact, emergency physicians were generally bad at all phases of follow-up care. They rarely referred patients for diagnostic tests, they almost never demonstrated use of an auto-injector, and seldom explained that auto-injectors have an expiration date.

Another disturbing finding from the survey, Zitt said, was that many physicians of all types – even the allergists – mistakenly believed that some patients should never receive epinephrine.

In the same session, Akhil Chouksey, MD, reported that anaphylaxis care in a major teaching hospital usually failed to meet guidelines established by a consortium of allergy societies including the ACAAI.  In a 10-year review of anaphylaxis cases only 15% met the standards of care recommendations i.e. that epinephrine be administered within 30 minutes of triage, that auto-injectors be prescribed at discharge, and that patients be referred to an allergist or immunologist for follow-up investigations and treatment.

The review also found that in 26% of cases in which anaphylaxis was definitively confirmed, the patients never received epinephrine.  Antihistamines, such as benadryl (diphenhydramine), were given in nearly all cases but epinephrine was omitted in one-quarter. In fact, epinephrine was only the third most commonly administered medication, with corticosteroids such as methylprednisolone, taking the second spot after antihistamines.

During the question-and-answer period, an audience member suggested that, when patients present with relatively mild symptoms, the treating physicians may decide that epinephrine isn’t needed at that point.  Zitt countered, that this was a very dangerous approach.

The national guidelines state explicitly that there are no absolute contraindications to epinephrine. Nevertheless, 16% of the pediatric allergists and 32% of the other allergists said there were such contraindications, as did 38% of adult primary care and emergency physicians.

Also common were beliefs that schools, restaurants, and ambulances always stock epinephrine. In fact, Zitt said, there are no general requirements for schools or restaurants to do so, and approximately half of all ambulances do not have epinephrine on hand.

Clearly there is much work still to be done in terms of education.  SRxA’s Word on Health suggests a first step would be to instill a healthy fear of anaphylaxis into doctors and the general public while simultaneously removing the fear of epinephrine.

Or as Dr Zitt says, “Give epinephrine first, ask questions later.”

Should new drugs wear a ‘Proceed with Caution’ label?

SRxA’s Word on Health was alarmed to read a new study showing that almost a quarter of prescription drugs approved in Canada over 16 years were later slapped with serious safety warnings or yanked from the market for safety reasons. As Canada’s drug safety agency operates much like the U.S. Food and Drug Administration (FDA), the study may reflect the state of drug safety in the United States as well.

When assessing a new drug, regulators at Health Canada and the FDA are entrusted with making critical and difficult scientific judgments that can affect the health of hundreds of thousands of patients in a matter of months after product launch.

And the cost of error may be high given that the number of people exposed to unsafe drugs may be in the millions.

University of Toronto health policy researcher Dr. Joel Lexchin looked at the 434 drug approvals that moved through Health Canada’s drug-safety arm from the start of 1995 to the end of 2010.

About a quarter of the drugs approved in that period received a fast-track deliberation known as a “priority review” which lasts 180 days instead of the typical 300 days.

Lexchin found that drugs approved this way were 50% more likely to end up with safety warnings, compared with drugs approved according to the customary deliberation period.

And while you might assume that the most-risky drugs would be those those fast-tracked for approval for life-threatening diseases such as cancer and HIV, Lexchin discovered they were no more likely to have safety concerns than drugs fast-tracked for less serious illnesses.

That was a surprise, because regulators could be expected to accept some heightened risks when approving new medications to treat serious illness.

In an accompanying editorial, Thomas J. Moore of the Institute for Safe Medication Practices suggests that new drugs should carry special labeling for their first three years on the market, so that doctors are reminded to prescribe with caution.

“Getting faster access to newer, less-thoroughly tested drugs is at best a mixed blessing,” said Moore. “For the first three years after approval, new drugs should carry a special warning akin to the black triangle used in Britain. It should be prominent and mean to every physician, ‘New Drug: Caution Indicated.’ ”

That caution may be worth remembering by both physicians and patients when considering switching to new drugs.