Thursday, January 31, 2008

Dr. Nash's Blog

A few months back, I met with Dr. David Nash, The Dr. Raymond C. and Doris N. Grandon Professor and Chairman of the Department of Health Policy at Jefferson Medical College of Thomas Jefferson University in Philadelphia. He is one of the KOLs in Health Policy and had done a significant amount of research in medication non-compliance/adherence. In his latest Health Policy Newsletter, there is a mention of his blog. I checked it our today and found this presentation. It is on medication non-adherence and how reduced co-pays save employers money in the long run and improve healthcare outcomes, specifically with chronic diseases.

I have posted a link to his blog in my blogroll.

Enjoy the presentation.

Wednesday, January 16, 2008

EC Devised Medication Delivery In A Fake Tooth

I found this on Science Centric and thought it interesting. Will comment later in the day. Of course Dr. Showalter at AlignMap has a fantastic post on this subject - with illustrations and great pics too boot.

A new prosthetic tooth that releases a controlled dose of medication at regular intervals may achieve a goal that has eluded doctors for 2500 years: finding a way to help patients follow treatment. ‘Keep a watch also on the faults of the patients, which often make them lie about the taking of things prescribed,’ warned the father of medicine, Hippocrates, 2500 years ago.
In the 1980s, Dr C Everett Koop, probably the best-known US surgeon-general, famously summarised: ‘Drugs don’t work in patients who don’t take them.’

Not much has changed. Studies indicate that up to 50% do not take their medicine — some forget, others deny the need for it. Still others take the wrong medication at the wrong time, or the wrong dose.
At best, it invalidates patient care. At worst, it endangers their lives. It is an intractable problem that has existed as long as medical practice.

But perhaps not for much longer. IntelliDrug, a project funded by the European Commission, has developed a system that delivers controlled drug doses at appropriate intervals, keeping the dose delivered within the exact therapeutic window. Better yet, it is easy to maintain and requires no invasive procedure.

The answer to the 2500 year-old compliance conundrum? A prosthetic tooth, just two molars in size, containing a reservoir, valve and programmable timing controls. It can even be controlled by infrared, which allows doctors to adjust doses during the course of treatment. Ultimately, it could allow patients on pain medication to self-medicate, if necessary.

‘The oral cavity is very accessible, so the device can be easily installed, refilled or have its batteries replaced,’ says Dr Ben Z Beiski, IntelliDrug co-inventor and project manager. ‘But passing the drug through the buccal (cheek) tissue also means much greater bioavailability.’

Bioavailability refers to the body’s capacity to absorb a substance. ‘Our evolution has designed us so that the body rejects or impedes alien substances and large, unusual molecules,’ says Dr Beiski. Molecules like those, typically, that make-up many modern drugs.

The upshot is that most drugs suffer from the first-pass effect. Between stomach acid, the gastrointestinal tract and, finally, the liver much — or even all — of a given dose is eliminated before it hits the bloodstream, where it does its work. ‘That’s why we need intravenous injections, to avoid the first-pass effect,’ explains Dr Beiski.

But IntelliDrug delivers the dose to the buccal tissue, on the inside of the cheek, where the body absorbs drug doses much more easily. Doses can be smaller and take effect quicker.

Here is how it works. The micro-system contains a reservoir and release mechanism; a programmable circuit, micro-sensors, an infrared sensor, micro-actuators and batteries. All housed in a tiny package. The circuit acts like a miniscule computer, releasing the dose required at the right time.

Ultimately, the batteries should last three months. Refilling the reservoir would vary, depending on the type of drug and dosage, but could range from every week to every month. In a later system, the team hopes to use radio-frequency identification (RFID) and later GSM telephony to communicate with the system.

It is a demonstration of the power of multidisciplinary co-operation between several scientific disciplines like micro-systems, micro-fluidics, dentistry, and pharmacy.

So far, the device has been tested successfully on pigs, which have similar oral characteristics. In November 2007, IntelliDrug enters human trials with twelve volunteers following naltrexone therapy, a heroin addiction treatment. If trials go well, IntelliDrug could be on the market in three years.

If successful, it could revolutionise treatment. The device can be applied to any drug, and Dr Beiski sees applications for hypertensive patients to combat morning increases in blood pressure. Chronic pain, diabetics and Alzheimer’s patients could benefit, too, making it an attractive system for patients and doctors.

For pharmaceutical companies, it is even more attractive, offering the equivalent of patent protection for generic drugs using the system. The combination would be protected by IntelliDrug intellectual property.

But perhaps most important of all, it will mean, finally, an end to the 2500 year-old patient compliance conundrum.

Tuesday, January 15, 2008

CVD Literature Review and Some Stats from the AHA

This is a literature review of noncompliance in... well the title tells the tale. I will post some comments on the end. This was found on, but I am pretty sure the paper is from a conference on hypertension from 2006 in Spain.

The economic consequences of noncompliance in cardiovascular disease and related conditions: a literature review

Objectives: To review studies on the cost consequences of compliance and/or persistence in cardiovascular disease (CVD) and related conditions (hypertension, dyslipidaemia, diabetes and heart failure) published since 1995, and to evaluate the effects of noncompliance on healthcare expenditure and the cost-effectiveness of pharmaceutical interventions.

Methods: English language papers published between January 1995 and February 2007 that examined compliance/persistence with medication for CVD or related conditions, provided an economic evaluation of pharmacological interventions or cost analysis, and quantified the cost consequences of noncompliance, were identified through database searches. The cost consequences of noncompliance were compared across studies descriptively.

Results: Of the 23 studies identified, 10 focused on hypertension, seven on diabetes, one on dyslipidaemia, one on coronary heart disease, one on heart failure and three covered multiple diseases. In studies assessing drug costs only, increased compliance/persistence led to increased drug costs. However, increased compliance/persistence increased the effectiveness of treatment, leading to a decrease in medical events and non-drug costs. This offset the higher drug costs, leading to savings in overall treatment costs. In studies evaluating the effect of compliance/persistence on the cost-effectiveness of pharmacological interventions, increased compliance/persistence appeared to reduce cost-effectiveness ratios, but the extent of this effect was not quantified.

Conclusions: Noncompliance with cardiovascular and antidiabetic medication is a significant problem. Increased compliance/persistence leads to increased drug costs, but these are offset by reduced non-drug costs, leading to overall cost savings. The effect of noncompliance on the cost-effectiveness of pharmacological interventions is inconclusive and further research is needed to resolve the issue.

Yes, we have repeatedly seen that increase medication adherence leads to increase medication costs. This is a given, just like any consumption increase. With diseases that have nor apparent symptoms, other than a heart attack, it is hard to argue the case that in the long run, spending more on your medication will lower your overall healthcare costs. Event hough it is the truth and I believe it, it is sometimes hard to argue because in three years, there will be someone else to pick-up the bill. Whether it is a different employers, healthcare plan or the government, people want to shift the cost to the next person.

I was reading the AHA's new report on CVD, and I knew that the numbers were pretty high, but a person dies every 37 seconds from CVD, totaling 2400 Americans a day. In 2008, 770,000 Americans with have a new coronary attack, with 430,000 expected to have a recurrent attack. Every 40 seconds someone dies from a stroke - that is one in seventeen deaths in the US. In 2004, heart failure was mentioned in 1 in 8 deaths. 80,700,000 Americans have 1 or more types of CVD.

These numbers are crazy. We are a sick nation that needs to be healed. Starting at childhood with diet and exercise, these numbers can be decreased, probably not in my lifetime, but hopefully my son's. My father had a mild heart attack last year, and it was a real wakeup call for him at 63. Now he is on more medication and he is adherent.

Sorry for the rant, but it has been on my mind today.

GERD for Kids!

The only this this really has to do with medication adherence is that parents often stop giving their children medication when they feel better. The problem is that if they discontinue the medication before the cycle is through, the GERD strengthens. This only caught my eye because my son suffered from it for the first 5 months of his life and had to take Prevacid before each meal. My wife, COurt, was freaking out because she did not know why he was always throwing up and arching his back. If you are a parent out there and see these symptoms, contact your pediatrician! I did not realize it was so common.

This is from

About one-third of Americans experience gastroesophageal reflux disease (GERD) — a disease traditionally associated with stressors accompanying adulthood. But GERD is emerging as a common childhood condition, as well. GERD in children may present differently or be more difficult to diagnose, and tailored approaches may be required to manage the disease in children.

Gastroesophageal reflux (GER) is a benign, physiologic process common in infants. More than 50% of healthy infants experience a passive return of stomach contents into the esophagus during their first several months of life. GER incidence then peaks and usually resolves by the time an infant celebrates his or her first birthday.

"GERD is worrisome for parents, and we frequently get referrals from primary care offices," says Rosemary Young, APRN, MS, CGRN, a pediatric gastroenterology nurse at the Boys Town Medical Center in Omaha, Neb. "Parents expect us to have an easy remedy."

Through childrens' eyes

Young children may not be able to verbalize or describe GERD symptoms. Infants and babies usually present with full-blown spitting up or vomiting. When the episodes are frequent, especially beyond 6 months of age, GERD is suspect.

Children also may demonstrate pain with irritability, constant or sudden crying, or back arching. If they can speak, they may describe abdominal pain above the navel, chest pain, or a burning sensation in the throat. When children present with the following signs, clinicians may proactively treat for GER without endoscopic confirmation of esophagitis:

• Pickiness about foods or textures, gagging or choking, or poor weight gain or weight loss

• Respiratory signs such as bad breath or frequent runny nose, sore throat, sinus infection, bronchitis, wheezing, asthma, nighttime cough, or a hoarse or deep voice

• Frequent waking, frequent ear infections or congestion, tooth enamel erosion, excessive salivation or drooling, or intolerance of pressure on the stomach

GERD solutions for children are not always clear-cut. "GER requires intervention when the reflux results in esophagitis — inflammation or tissue damage to the esophagus," says Nancy Goldberg, APRN, MSN, BC, PNP, of Children's Hospital Boston.

Many children under age 12 have "silent" GERD; they do not visibly regurgitate or describe heartburn. Signs to watch for include —

• Poor weight gain or failure to thrive

• Signs of esophagitis, such as heartburn that worsens upon bending, difficult or painful swallowing, or mouth sores

• Dry cough and asthma symptoms (wheezing, apnea, pneumonia, chronic sinusitis)

Pediatric GERD represents a fairly dynamic area of study with evolving management practices. Goldberg says impedance studies (computer evaluation of the contents of the esophagus through a nasogastric tube, usually for an 18- to 24-hour period) are being used to examine children with suspected GERD.

Eosinophilic esophagitis (EE), a chronic condition with persistent or relapsing symptoms, is linked to the theory that food allergens are involved in increased mucosal eosinophils. When suspected GERD is unresponsive or only partially responsive to acid-blockade therapy, or when older children say they feel as if they can't swallow, it is standard practice to conduct endoscopy and biopsy of the esophagus to evaluate for eosinophils. Generally, EE is diagnosed with greater than or equal to 15 eosinophils per high-powered field in the esophageal mucosa. When EE is diagnosed, clinicians usually conduct allergy tests to identify and eliminate the offending food allergen(s); however, it also is possible that environmental allergens — not food allergens — are the source of the EE.

Gastric acid reflux is thought to be the primary mediator in GERD; therefore, patients with GERD are treated primarily with acid suppression agents. With EE, food allergens are thought to be the primary mediator, and removing food allergens has been shown to treat both the symptoms and the underlying histopathology. In some cases, co-therapy with topical corticosteroids and/or acid suppression may resolve acute symptoms.

A debate is ongoing about the possible link between asthma and GERD. The two conditions are thought to feed off each other through multiple pathways. In many cases, GERD is secondary to an underlying condition such as food allergies or neurological impairment.

Help for children, parents

The initial approach to GERD treatment with children, particularly infants, is conservative, Young adds.

"We try to figure out the cause first," she says. "Usually we suggest lifestyle alterations and assure parents this may be a normal process that will resolve naturally."

Dietary management differs in children and in adults, according to Young. "We tell adults to avoid spicy food, fats, caffeine, and alcohol," she says. "With children, we think in terms of hypoallergenic diets — we tell parents to try to avoid food allergens that may cause GERD." Pediatric clinicians commonly recommend thickening infant formula with cereal to reduce regurgitation, but this practice could open the door to potential allergic response.

If symptoms persist, children may be treated with over-the-counter antacids such as Maalox or Mylanta. The next step is an H2 blocker such as ranitidine and then a proton pump-inhibitor such as lansoprazole, which has a pediatric indication. Goldberg reminds nurses that medications for children are dosed by weight and that children often metabolize drugs differently. Proton pump inhibitors, for example, are metabolized more rapidly by children, so dosages must be adjusted.

Drugs that accelerate gastric emptying such as metoclopramide rarely are used for children with pediatric GERD because of the risk of potential adverse events.

Parents require ongoing support, especially when babies are fussy. "Nurses should talk to parents about the lower esophageal sphincter (LES), a high-pressure zone of muscles around the bottom of the esophagus where it connects to the stomach. It takes time for the LES to fully develop properly in babies," says Young. "In older children and adults with GERD, the LES may be malfunctioning by relaxing at the wrong times, or the pressure may be consistently too low."

Nurses should ask parents questions about how often their children regurgitate, what the volume of regurgitation is, how much their children eat at one sitting, and how frequently they eat.

"When nurses educate and assess, it can save parents and physicians a lot of agony," Young says.

Thursday, January 10, 2008

Guanfacine XR Is Effective and Improves Adherence with ADHD

This is just the first couple of paragraphs from a MedScape story I read. I always find it sad when children are prescribed meds for mental instabilities. But we do live in a medicated world and pills fix problems. As I always say, anything that improves adherence works for me, but check out my comments at the end.

I went to high school and college with kids who were diagnosed ADHD and took Ritalin. I never really understood why. I mean isn't concentration something you learn in grammar school? Would any child choose to focus on their school work unless they were taught how to do so?

You don't automatically know how to study or prepare for an exam or write a term paper without learning how to do it. I guess when you call a kid spaz and they have some energy, you should just medicate. I really am not looking forward to seeing what happens to my son in a few years when he starts to act up and the psychologist recommends putting him on medication.

There is more technical information at MedScape, but it is not relevant to my comments.

January 9, 2008 — Guanfacine extended release (Shire Inc.) at doses of 2, 3, and 4 mg/day was effective vs placebo and was generally well tolerated in a multicenter, 8-week, fixed-dose escalation study in children aged 6 to 17 years old with attention-deficit/hyperactivity disorder (ADHD).

The study, part of a new drug application, is published in the January issue of Pediatrics.

"I think it is very important for clinicians and families to have alternative treat a condition in which many patients cannot tolerate or do not respond to treatment," lead author, Joseph Biederman, MD, from Massachusetts General Hospital in Boston, told Medscape Psychiatry, adding that guanfacine extended release offers a unique option for patients who do not do well taking other treatments.

Any Stimulant Is Ineffective for 1 in 4 Patients

ADHD is a very prevalent, very morbid disorder, said Dr. Biederman. Although stimulants are the mainstay of treatment, any 1 stimulant is ineffective in 25% to 30% of cases, the group writes.

Guanfacine extended release, a nonstimulant, is an alpha-2 adrenergic agonist like clonidine (Catapres; Boehringer-Ingelheim) but is more selective. Both of these drugs came to market as antihypertensive agents, said Dr. Biederman, adding that they have been used off label in psychiatry for many years for managing withdrawal reactions, treating severe hyperactivity in ADHD, and, more recently, treating insomnia that frequently develops as a consequence of stimulant treatment.

The study aimed to assess the efficacy and safety of guanfacine extended release for the treatment of children and adolescents with ADHD.

The trail was conducted in 48 centers in the United States. Patients aged 6 to 17 years old who met the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for ADHD were eligible to participate.


Did you read what Guanfacine came on to the market for? Did you read what it was prescribed off label for? These really disturb me that all of a sudden, hey, lets give it to kids who are too stimulated already! I do not know that much about medicine or science, but I would assume that there is a large gap between hypertension and ADHD.

Maybe I am wrong.

When a junkie goes through withdrawal, uh, I guess it is just like a hyperactive child - this sort of makes sense to me with frazzled nerves and brain functions. Also insomnia? I know that for people who do not suffer from ADHD, taking medications that are prescribed for ADHD makes them speedy, but puts them to sleep?

I need to learn more to properly comment on these items, but this is what I thought when I read it.

Stay adherent!

Wednesday, January 9, 2008

Study Proves Lower Co-pays Equal Better Medication Adherence

Here is a piece about a study that I read yesterday in a bunch of places, but this has the most information from ScienceDaily's website and adapted from materials provided by University of Michigan Health System. It is so concise that I really cannot comment on it, save a few things which are at the end of this post.

ScienceDaily (Jan. 8, 2008) — As 2008 begins, millions of Americans are having to dig deeper into their own pockets every time they refill a prescription or see a doctor.The reason? Higher co-payments that took effect January 1, as employers try to deal with the rising cost of health insurance by making employees and retirees pay more.

But a new study finds that instead of going up, co-pays should go down -- at least for some people taking some drugs. Just by cutting a few dollars off the co-pay, the study suggests, employers could increase the chances that employees with chronic illnesses will take certain preventive medicines. And that could pay off in the long run, in the form of fewer hospitalizations or emergency room visits for employees with diabetes, high blood pressure, asthma and other conditions.

Specifically, the study showed that a major private employer significantly increased the use of important preventive medicines among its employees by automatically making some medications free, and slashing co-pays for other drugs by 50 percent. Meanwhile, another employer that kept its co-pays the same didn't experience the same increase in use of preventive medicines.

The difference in medication use between chronically ill employees at the two companies was sizable -- even though all the employees in the study were also enrolled in special programs designed to help them take control of their diseases.

The study is published in the January/February issue of the journal Health Affairs by a team led by University of Michigan and Harvard University researchers. It is the first rigorous, controlled trial of a concept called "value based insurance design."

That concept, introduced in the late 1990s by members of the research team, is based on the idea that there should be few barriers standing between a chronically ill person and the medications that can keep them well enough to work and to avoid health crises and complications related to their disease. Even a barrier of a few dollars is enough to keep people from using the medicines they need the most.

"All research to this point has shown that individuals will not buy important medical services even if there's a small financial barrier: $5 or even $2," says senior author Mark Fendrick, M.D., of the U-M Medical School and School of Public Health. "This study showed that when you remove those barriers, people started using these high-value services significantly more. These results bolster the idea that health insurance benefits should be designed in ways that produce the most health per dollar spent."

Fendrick and first author Michael Chernew, Ph.D., of the Harvard Medical School, co-founded the Center for Value-Based Insurance Design, based at U-M. They conducted the study with co-authors from ActiveHealth Management, which had been retained by both companies in the study to provide voluntary disease-management programs for employees and dependents with 32 medical conditions.

Members of GlaxoSmithKline's Health Management Innovations division also took part in the study, which was supported by unrestricted funds from both GSK and Pfizer, Inc. The employers involved in the study have asked to remain anonymous. During the study period, ActiveHealth Management was acquired by Aetna, a major insurer, but there was no impact on the study.

The study involved more than 35,000 employees and dependents at the company where co-pays were reduced (Company A), and more than 70,000 employees and dependents at the other (Company B). All had regular phone contact with nurses in their disease management programs, who offered help based on each person's test results, medication use, doctor visits and other health information.

The researchers looked at use of five classes of drugs: heart-protecting ACE inhibitors and angiotensin-receptor blockers; blood-pressure-reducing beta blockers; diabetes medicines including blood sugar-reducing drugs and insulin; cholesterol-reducing statins; and asthma-calming inhaled steroids.

In the study period, co-pays at Company A went from $5 to $0 for generic drugs, from $25 to $12.50 for name-brand drugs on the company's preferred drug list, and from $45 to $22.50 for non-preferred name-brand drugs. Co-pays at Company B stayed around $29 for brand-name drugs and $16 for generics.

As part of the disease management program at both companies, people who weren't already taking preventive medications related to their conditions were contacted automatically to let them know about the importance of those specific medications. At Company A, they were also informed of the reduced co-pays. For all Company A employees, the co-pay reductions were made automatically at the pharmacy.

In just one year, the appropriate use of the preventive medicines at Company A increased significantly in four of the five drug classes, with inhaled steroids for asthma being the exception. The increase in use of statins was more modest than the increases in use of ACEs/ARBs, beta blockers and diabetes drugs.

And, the results show that "nonadherence" -- a term used to describe a situation when someone should be taking a medicine but isn't -- decreased between 7 percent and 14 percent, depending on drug class.

Chernew notes that the study was not designed to assess whether increased adherence to preventive drugs had a measurable impact on employees' and dependents' health, or their use of costly services such as hospitalization and emergency care.

"While future studies need to be done to actually quantify this specifically, there is considerable evidence that use of the classes of medication in this study will reduce the frequency of adverse clinical events and associated hospitalizations and ER visits," he says. "We believe that tailoring co-pays to the individual patient can improve the efficiency of health care spending when applied to this type of high-value health service."

The new data provide the first rigorous, controlled analysis of the impact of a "clinically sensitive" health benefit design. Previously, employers such as office-equipment maker Pitney Bowes and the city of Asheville, NC have reported increased adherence and decreased use of health services among chronically ill employees who had their co-pays reduced.

Meanwhile, other employers have launched their own such programs without waiting for a controlled study to convince them of the potential benefits. In fact, the University of Michigan is currently offering free or reduced-price medications and tests to more than 2,000 of its employees and their dependents who have diabetes.

That project, called MHealthy: Focus on Diabetes, is being managed by the Center for Healthcare Quality and Transformation and may produce its first data this year.

"When I told my mother about this study, she turned to me and said 'I can't believe you had to spend all that money to show that if you make people pay more for something they'll buy less of it,'" says Fendrick. "But we needed to show with a carefully done study that if we did lower barriers that people would utilize these essential medical services more. And as always, my mother was right."

In addition to Fendrick and Chernew, the study's authors are Mayur Shah, Arnold Wegh, Stephen Rosenberg, and Iver Juster of ActiveHealth; Allison Rosen of U-M Medical School and School of Public Health, who is leading the analysis of the University of Michigan diabetes project; and Michael Sokol and Kristina Yu-Isenberg of GSK.

As it has been proven in the past, lower co-pays = betters adherence. The question is, who is going to pay? Pitney Bowes is picking up the tab for their employees, but they have one of the best employer healthcare programs and they see the value. Since insurance companies are always trying to make more of a profit, with they cover more prescription costs and realize it will pay off in the future? See the Aetna post of last month

My own experience with copays almost affected my adherence, but I know better. When we switched over to a HSA program my co-pays went up by a ridiculous amount - almost 500%. My wife and son were also on two medications plus my two, and we were spending about $400 a month! Luckily we switched over to a regular plan and they went back down to $20 a script. Point being, with any financial barriers, adherence suffers.

This study is almost like a "Duh, of course", just like Dr. Fendrick's mother said, but it is important for insurers and employers to realize that cost is definitely a part of medication adherence.

Stay compliant! Remember to take your meds.