Monday, December 31, 2007

iPhone Can Tell You Which Pharmacies Are Open in Germany

It seems as if everyone wants to do eHealth for the iPhone! From the Website eHealth Europe:

A new Web 2.0 iPhone service has been introduced in Germany, which shows what pharmacies are open during Christmas and a map of how to get there.

The new service details Christmas opening times and locations for nearly all of the 21000 pharmacies in Germany. The service is offered by, one of the biggest German-language pharmacy websites.

Opening the website prompts the user to enter their postcode, which then returns a choice of nearby pharmacies displayed, together with directions, using Google Maps.

As well as details and locations of pharmacies that are open, the service also includes details of GPs on duty, though this part of service is still under development and doesn’t yet cover the whole country.’s is one of the first iPhone specific medical services in Germany, where the iPhone has been available for two months. However, other online pharmacy services such as e-medication still remain at an early stage in Germany.

“Pharmacy networks and pharmacy marketing alliances are reluctant to even think about the possibility of using electronic medication services to help patients keep track of their medication electronically“, Harald Sondhof of the Tübingen-based health-IT company Careon, told E-Health Europe.

This, he stressed, was wrong because e-medication services not only improve medication safety and patient compliance but “also can be used to win or keep customers.”

Careon is offering a web-based, patient-centred personal health record (PHR). It is available in various forms dependent on the adoption scenario. One version focuses on medication issues, with services like interaction check or reminder functions for medication times. Pharmacists could offer it to patients as an additional service.

Sondhof managed to persuade ten German pharmacies to take part in a pilot project, due to start early 2008. The pharmacists will offer the e-medication PHR service to chronically ill patients. “It will be easy to use, because it is integrated into the enterprise resource planning software. So pharmacists can add medication to their customer's PHR almost automatically”, Sondhof said. The IT partner in the project is ADV, and with around 800 pharmacies as customers it’s a medium size provider of pharmacy IT in Germany.

Given their affinity with the iPhone, pharmacists might be persuaded of e-medication services as soon as PHR are offered in iPhone versions. Indeed, the Walldorf-based company ICW has recently presented an iPhone version of its PHR ‘LifeSensor’.

Another reason to consider the iPhone a perfect e-health-present for Christmas 2007?


Tuesday, December 18, 2007

Dr.First For The iPhone

With mobile platforms opening up to outside vendors more and more applications can be developed. For medication adherence, eprescribing plays a role - mostly with medication errors, which account for 12% of so of all medication non-adherence. Can you read your MDs handwriting? Dr.First is a great application and now an MD can send the prescription in while speaking to the patient and it will be ready for pick-up by the time the patient gets to the pharmacy. I am also a fan of tablet PCs, where MDs can also access their patients EHR, but I haven't seen any news about them lately.

This is right off the BUSINESS WIRE:
ROCKVILLE, Md.--(BUSINESS WIRE)--DrFirst™, the leader in electronic prescribing and medication reconciliation services, today announced that physicians will have access to an unparalleled e-prescribing experience on the Apple iPhoneTM through DrFirst’s RcopiaTM e-prescribing system. For the first time, physicians and their staff will be able to perform all of the essential functions of electronic prescribing in real-time on a mobile browser through a WiFi or wireless carrier’s broadband connection.

RcopiaMini is formatted for the smaller screen of today’s mobile devices and allows providers to easily navigate a full-featured version of Rcopia on this exciting new platform. DrFirst designed the application to provide a real-time interaction between physicians, pharmacies, and health plans, so there is no need to update or sync the device.

“Now physicians can quickly, safely, and securely prescribe from anywhere—through the always-on connectivity of the iPhone, the WiFi connection of the iPod Touch, or while seated at the desktop computer in the practice,” said Peter N. Kaufman, Chief Medical Officer of DrFirst, Inc.. “DrFirst’s goal is to ensure that its new web-based, mobile Rcopia experience delivers the same high levels of innovation and usability as the original Web version.”

To be useful to physicians, e-prescribing must be easily and securely accessible. With the addition of the iPhone and iPod Touch, DrFirst provides physicians with a broad set of eprescribing platforms, including Apple, Treo, and HP iPaq handheld devices as well as desktop and tablet systems.

E-prescribing on the iPhone with RcopiaMini allows physicians to provide a higher level of patient service and safety, streamline practice workflows, and save time and money through the efficiency of electronic medication orders, renewals and formulary checking. New prescriptions and renewals are sent electronically to the patient’s retail or mail order pharmacy.

RcopiaMini checks for patient insurance eligibility, formulary, and patient medication history. The application also offers clinical decision support tools to check prescriptions for drug-drug and drug-allergy interactions and appropriate dosing.

Busy doctors, large practices, and health systems require software that is adaptable to the practice workflow and that draws the practice staff into the prescribing process. To meet this need, RcopiaMini is designed to be accessible to all staff members, to be highly configurable and to accommodate workflow features that make it a perfect solution for
groups of any size.

Thursday, December 6, 2007

My Health

In February of this year, I was diagnosed with high Triglycerides and high Cholesterol. Mostly hereditary - have you seen the Vytorin ads? - and somewhat my diet. My doctor put me on Tricor, and I have been pretty adherent. In July, I stopped taking it for two weeks while I awaited a new script but otherwise everyday.

My new doctor (my old MD went back to research) didn't know if Tricor was the right drug, so he sent me for blood work.

He gave me the results today.

The good news is that all my levels went down: Total 247, LDL 149, HDL 38 and Triglycerides 301. The bad news is my HDL went down 10 points (very bad considering this is the "good" cholesterol and 40 or higher is recommended). The LDL went down 50 points (very good 130 is recommended), and my total is only 47 points out of the top part of the spectrum. So I am feeling pretty good about myself. I still need to eat better, lose more weight and exercise more effeciently - but who doesn't?

The point to all of this - other than letting you all know about my health, which is top of mind in your lives - is that within two minutes of questioning, my MD asked if I had been taking Tricor regularly. I said yes, except for that two week period, and he said "Everyday?" And I said, "Yes, everyday." I was going to tell him that I am the Director of Corporate Development for a healthcare technology company that focuses on enabling medication adherence and that a get daily text, voice and email reminders, but I didn't need to get into it.

It then occured to me that if I said I was taking the Tricor (see White Coat Adherence) and was not, that all of his diagnosees would be off. If he thought the Tricor wasn't working (technically it would not be working because I would not be taking it), and prescribed something else - it could really mess up my system. I never really thought about medication adherence this way, only that by not taking your meds, your condition gets worse.

My MD was happy to see my numbers and my weight go down and he gave me a choice: keep losing weight, eat better and exercise and see what happens in three months, or do all of that and take another medication in conjunction with the Tricor. He wanted to make sure I would stay adherent to another medication. Putting me on Niacin would increase my pills to 4 a day (I am on another med in the morning and bedtime). 32 million people are on 3 or more medications. Plus, he gave me an antibiotic to take for 10 days to knock a sinus infection out which I have had for two weeks.

So now, my total pill count is at 5 pills, 4 medications.

The better news is the rare blood disease he was worried about only needs to be checked every three months. So there is more time at the lab for me. If I stay adherent to the Tricor and the Niacin, and loose more weight (he said 10 lbs), and eat better (I do have the occational french fry, and ice cream) - I should have all my levels in the right range and not have to take any medications.

This would be optimal.

So, I will set up more reminders for myself, get into the routine of taking a new drug and everything should be right as rain.

As long as there are not any horrible side effects - he mentioned hot flashes - and the drugs fall into my formulary. By my son's 1st birthday, I will be a new man!

Wednesday, December 5, 2007

Aetna's Healthy Actions Rx-Savings

There is a signifacant correlation between the cost of a drug and one's adherence to the drug. eg. Drug X costs me $125 a month and after two months, I don't really see any results. I will stop taking that drug. Now my employer tells me they will pay for drug X, so I go back on it and stay the course until I see a change. That is if I remember to take my drug and the side effects are not too bad!

Marriott is doing a great service for their employees considering the majority of them most likely earn above minimum wage and are supporting a family with their healthcare benefits. They also will see the benefit with lower absenteeism, and higher productivity. Kudos to Aetna for their CareEngine System and offering so many programs to lower costs to their members.

This is straight off the BusinessWire press release:

HARTFORD, Conn.--(BUSINESS WIRE)--Aetna (NYSE:AET) today announced the launch of Aetna Healthy ActionsSM Rx-Savings, an incentive program under which co-pays for individuals enrolled in self-funded benefit plans who have high risk clinical profiles and are taking medications for chronic health conditions including asthma, diabetes, high cholesterol, high blood pressure, and heart disease are paid in whole or in part by their employer. The program is designed to encourage member compliance with medications shown to be essential, according to the evidence base, to the effective management of these conditions for high risk members.

“The use of evidence-based medicine in combination with pharmacy benefit design may significantly help to improve the overall quality of care for members with the targeted chronic health conditions by reducing the cost barrier to patient compliance with recommended drug therapies and treatments,” said Ed Pezalla, M.D., National Medical Director, Aetna Pharmacy Management. “This program is one of several value-based plan design initiatives we are deploying to our member population to help promote better health outcomes, reduce costs, increase satisfaction and over time, lower cost trend for the employer.”

Aetna Healthy ActionsSM Rx-Savings allows self-funded employers to offer a drug class co-pay discount to employees based on a member’s clinical risk profile and relevant evidence-based standards. Eligible members are identified through ActiveHealth Management’s CareEngine® System technology which can proactively identify at-risk individuals who currently use a drug covered in the program, as well as those who could benefit from use of a drug covered in the program. Once identified, an outreach mailing is sent to the member to notify them they are eligible for co-pay discounts. If the member is not currently using a drug covered in the program, an outreach mailing is conducted to both the member and his or her physician.

Marriott International, Inc. is a pilot customer for the program.

“Reduced co-pays resulted in increased adherence rates, which we believe may lower the number of costly medical emergencies and hospitalizations in our workforce, and ultimately help alleviate our health care costs over time," said Jill Berger, vice-president, Health & Welfare for Marriott International, Inc.

The drug classes and conditions applicable in this program include: anti-diabetic medications, inhaled steroids for asthma, beta blockers for cardioprotection, ACEI/ARBs when needed for cardiorenal protection and statins for those who have high-risk conditions such as diabetes and CAD; with a recommended discount of up to 100 percent off the co-pay for generics and up to 50 percent off the co-pay for preferred brands. This program has been piloted with certain self-funded employers and will be available more broadly to all self-funded customers January 1, 2008.

Clinical studies have shown that co-payments and deductibles can impact patients' compliance with medications and treatment plans. One example is a 2004 study tracking patients with high cholesterol that found patients who paid lower co-pays for statins were more compliant with their treatment regimen.1

In October, Aetna launched a groundbreaking study in partnership with Brigham and Women’s Hospital to follow drug compliance in members who have had a heart attack and who are on maintenance drugs such as beta blockers. In the study group, individuals’ co-payments, co-insurance or deductibles for certain drugs proven effective in managing their condition will be paid for by Aetna or the employer (depending on the nature of the coverage) rather than the member. The study is the first of its kind to test the impact of variable or no co-payments on the outcomes of certain chronic diseases.

Aetna has a unique combination of consumer-directed experience, member information and technology that can help provide better understanding of patient decision-making and potentially encourage them to better manage their condition with incentive-based offerings. With a number of programs in place including Save-a-Copay, available first-dollar coverage of preventive medications within its Health Savings Account-compatible high-deductible health plans, and pilot programs with its largest customers, the company is committed to building, evaluating and deploying value-based plan design initiatives.

"Lower costs have been shown to help improve medication adherence and we believe this will lead to improved care and reduce costs," said Pezalla. "Health insurers and self-insured employers partially offset their costs of insurance by requiring co-payments, coinsurance or deductibles; however, they incur the costs of illness if a patient suffers further complications from chronic illness. This program offers real opportunities for promoting better care and reduced waste while promoting consumerism. As we gain a deeper understanding of the effect of reduced out-of-pocket costs on member adherence to prescribed therapies, Aetna will apply these insights to future benefit design efforts.”

Sunday, November 18, 2007

It Is Not A Small World (or US) After All

I found this article in Synapse, the USCSF, the student paper. I'm not one to talk being 15 lbs over my optimum weight, but if you go to the entertainment parks and anywhere large amounts of people congregate, you will actually see that there is a big problem in the US with obesity.

A New Motto for Weight Loss: Keep Disneyland Open By Alison Silvis

Look to Disneyland for the latest symptom of the obesity epidemic. The park’s “It’s a Small World” ride is simply too small to accommodate the extra 24 pounds the average American has packed on since 1960. Stalls and stops are so common that extra platforms have been built at problem hotspots along the ride. Now, the ride will be closing for ten months beginning in January for refurbishment with larger flume cars and deeper waterways.

As future health-care professionals, this is one more sign of the environment in which we will be practicing. Patients are getting heavier, more sedentary and in greater need of preventative care and support for behavior change. Evidence-based medicine should be the gold standard for such care. But we still cannot answer the simple question: how much weight gain is bad? And how much is good?

The November 7 issue of JAMA contains an article that adds to our understanding of the already-complex relationship between weight and health, but raises many questions about the supposed protective effect of being overweight. Knowing how to interpret articles and how to individualize research findings to a patient is our responsibility. But this is only one component of employing evidence-based medicine. It also means making sure patients understand the information, and then following up to see how they apply that information to their lives. This is easier said than done, of course, but that does not justify giving up.

The same issue of JAMA offered some hope in how to support long-term weight management behaviors, in the discussion of one physician’s efforts to manage the care of an obese patient with several health complications (“Clinical Crossroads: A 63-Year-Old Man with Multiple Cardiovascular Risk Factors and Poor Adherence to Treatment Plans”). The author, Dr. Bodenheimer, emphasized the importance of clinical care teams that work to merge a patient’s goals with clinicians’ goals. A patient’s participation in her care may be the single most important factor in adherence to medication, and presumably plays a fundamental role in determining adherence to behavior change.

In this sense, a clinician’s role may evolve into one of “self-management support,” providing information and resources to initiate and maintain healthy behavior outside of clinic visits. One promising model of this type of chronic care is at Health Partners Medical Group in Minnesota. There, patients receive previsit, visit, postvisit, and between-visit care from a variety of health professionals. Clearly, collaboration within the health professions and between clinicians and patients is essential to this model. Whether or not it improves patient outcomes is yet to be determined, but the current system is clearly failing.

We cannot afford to ignore the painful reality of the obesity epidemic. In Disneyland, when heavy patrons are disgruntled at being asked to step off the ride, they are offered a food voucher. In the world of evidence-based medicine, we need to challenge patients to confront the reality of their daily lifestyle choices, and then work with them to modify those that are unhealthy. We owe it to them.

Wednesday, November 14, 2007

Diabetes in the West Indes

You forget that even in paradise there are chronic diseases and medication adherence is important. To that statement, here is a diabetes program in St. Kitts/Nevis to celebrate World DIabetes Day.

From the Sun St.Kitts/Nevis by Akedia Christopher

The Rotary Club of St. Kitts is hosting a ‘Diabetes Day Camp’ Saturday at the St. Johnson’s Community Center in recognition of World Diabetes Day celebrated today.

President of the club, Leah Sahely, told the SUN in an interview that the event was organised in hope of helping diabetics “find answers to questions about managing this disease.” She added the “disease is serious and we are going to cover all aspects of diabetes.”

The day, as described by the Sahely, is going to consist of breakdown sessions which would enable question and answer segments at the end of each presentation. She added that letters were sent out to health centres and doctors alike asking them to identify patients to participate in the event.

She further mentioned they were presenting educational opportunities by way of lectures, on how to control the disease and “to reinforce the need for compliance.” This, she said, would act as a source of encouragement for diabetics to follow doctors’ orders and also to live healthy lives.

Sahely also mentioned that some of the doctors who will be making presentations include Bichara Sahely who would present an overview of the disease, Cavelle Hobson who would discuss medication availability and consequences of non-compliance and also Dr. Caroline Lawrence who would address cardiovascular complications which can be created and the importance of monitoring the disease .

Earl Clarke is also among the team, according to Sahely, and he is going to speak to the need for exercise and the value of it, along with dietician Magaret Stevens “who is going to talk about eating habits.”

Tuesday, November 13, 2007

Voice Technology To Help The EU

Thanks to Dr. Showalter, I now know how to post a link that works!

From Eureka, written by Tom Shelley:
Two very dissimilar applications – one in machinery, the other in medicine – are both being solved by relying on spoken rather than written information.

Printed instructions are said to be meaningless to around 20% of the European Population. This, combined with the 8 million blind and partially sighted people in Europe, contributes to nearly 200,000 deaths a year in the EU due to mis-dose and non-compliance of prescribed medication.

UK-based Pera has developed ‘talking packaging’ in the shape of Medi-Voice. The idea is to take current compliance monitoring, enhance it and combine it with speech technology in smart pharmaceutical blister packaging which than can give spoken instructions.

The packaging will be powered by thin film, flexible, photovoltaic laminates, with homogenisation of the photovoltaic and the polymer packaging through in-mould labelling. The speech system and compliance electronics will be developed onto a flexible PCB that will be incorporated by over-moulded into the packaging.

A piezo-electric sounder is also to be encapsulated into the polymer packaging during the injection moulding process. Dosage assurance will be achieved through the printing of conductive ink electrodes onto the blister sealing film that will input to the compliance circuitry.

Eureka Magazine Article

Thursday, November 8, 2007

A Little Shamless Promotion

I am not that technologically savvy - I let our programmers handle that end of the business - but I learned how to post pictures yesterday and wanted to share our booth at the 2007 Working Mother WorkLife Congress. We were exhibiting to launch our product offering to employers. Intelecare's Personal Reminder Platform increases medication adherence by sending user created reminders via email, text and voice messaging. We serve the needs of patients and caregivers via our website,, and with our API, our technology can be integrated into any exiting website as a fully branded adherence solution.

For example, Employer X has a wellness program on their website, with Intelecare's API, Employer X can offer medical reminders (ie. daily medication, refills, appointments, etc...) to their employees. Intelecare handles all the backend programming and message delivery. All the client needs to worry about it their front end design.

Reasoning? 23% of all employer health insurance costs are related to patient medication non-adherence. 64% of patients who are non-adherent cite they simply forget to take their meds. 45% of Americans are on medication. 50% of them are non-adherent. Thus shouldn't employers want to lower their healthcare costs by focusing on medication adherence - a very simple problem that costs the US $177 billion annually in lost revenue and unnecesssary healthcare costs? We think so.

Our API is also available to insurers, pharmaceutical companies, social health networks, EAP providers, and pharmacies. As part of our Enlighten Together program, we offer our Express (email only) solution to non-profits that focus on chronic diseases. All of our products and services are outlined on our website,

With that bit of promotion, I shall retire to find more information about this devastating pandemic that affects us all somehow. Please visit the NCPIE site, NCPIE Home to read their August report on medication adherence to find more facts and figures - as well as their call to action.

Stay adherent!

Alignmap Post

Dr. Showalter is passionate about medication adherence and has the clout to question reports and scoff at findings. I always enjoy reading his posts and he usually scoops me on a couple of items, like his latests post.

Medication Noncompliance With Statins - Same Old Same Old

Wednesday, November 7, 2007

A Different Approach to Medication Adherence

I found this tidbit from the US News and World Report website - just a press release. A different approach to staying adherent to medications and dealing with side effects:

From Health Day News
Spirituality helps older black American women with high blood pressure stick to the drug regimens that keep the condition under control, new research suggests.

Older black Americans tend to have poorer anti-hypertensive medication adherence than either younger blacks or white patients, even though adherence helps reduce hypertension-related health problems and deaths, noted a team from the University of Pennsylvania School of Nursing.

This study included 21 black women, average age 73, who were members of a Program of All Inclusive Care for the Elderly. The women had been diagnosed with hypertension for an average of 16.7 years, and they were taking an average of 3.3 prescriptions to battle the condition.

All the women said they used their spirituality to manage their medication adherence. As part of this process, identified as "Partnering with God to Manage My Medications," the women accepted personal responsibility for adhering to their medication regimen and used their spirituality as a resource to make decisions to remain adherent, to cope with medication side effects, and to increase their ability to deal with barriers that kept them from sticking with their medicines.

The findings suggest that incorporating patients' beliefs into hypertension treatment may help them draw on inner resources to improve medication adherence, the researchers concluded.

The study was to be presented Wednesday at the American Heart Association annual meeting in Orlando, Fla.

Friday, November 2, 2007

Online Rx program helping cut errors

Just an article about the automakers efforts to implement ePrescribing.

From the Detroit News by Sofia Kosmetatos

Online Rx program helping cut errors
Big 3's e-drug plan boosts the use of generics while reducing glitches, analysis shows.

A Big Three-driven effort to replace prescription pads with computers is significantly reducing patient risk from medication errors and helping increase generic drug use, according to an analysis released today by the Southeast Michigan ePrescribing Initiative.

Launched nearly two years ago, the first review of the initiative shows that it is not only protecting patients from the harmful consequences of medication errors, but is also helping them have better discussions with their doctors about medications at the time a prescription is written.

"The benefits of ePrescribing are overwhelming in terms of reducing medication errors, lowering prescription drug costs for patients and plans, and decreasing physician practices' administrative costs," said Marsha Manning, General Motors Corp.'s manager of Southeast Michigan Community Health Care Initiatives, in a statement.

Through the initiative, doctors access online software on computers in patient rooms to write the prescriptions, prompting discussions about generic alternatives, drug interactions and allergies at the time a prescription is written. The results are savings on drug costs and fewer medical complications, doctors and coalition members say. EPrescribing also eliminates doctors' handwriting as a source for error, and saves patients and doctors' offices time because the scripts are sent to pharmacies electronically.

The analysis of a sample of 3.3 million prescriptions showed:
• The ePrescribing technology sent alerts of severe or moderate drug interactions to doctors for about one-third of those prescriptions. Doctors changed or canceled 423,000 (or 41 percent) of those prescriptions.
• The technology informed doctors of more than 100,000 medication allergies, and doctors acted on 41,000 of these alerts.
• When an alert showed a drug was not on a formulary, the doctor changed the prescription to comply 39 percent of the time.

The initiative, involving the automakers, Henry Ford Health System, Blue Cross Blue Shield of Michigan and others, aimed to help doctors set up electronic prescribing in their offices.

The three automakers -- GM, Ford Motor Co. and Chrysler LLC -- are involved because they think the initiative can cut down on their health care costs, which add up to billions of dollars. So far, some 6.2 million prescriptions have been written by 2,500 doctors using ePrescribing technology, with more than 282,000 written each month. The coalition plans to extend the initiative through March 2008.

Generic drug use up
GM spokeswoman Carey Osmundson said it's difficult to quantify how much the company has saved with ePrescribing, but GM has seen increases in its rates of generic drug prescribing and compliance with preferred drug lists, both of which save money. For each 1 percent shift to generic drugs from a brand name, GM saves nearly $20 million, she said.
GM spent $1.5 billion on prescription drugs alone last year for 1 million enrollees, a growing tab it had worked for years to stem.

Henry Ford Health System conservatively estimates it is saving $4 million a year with ePrescribing, mostly from switching HAP patients from brand-name drugs to less costly generic alternatives.

That's not including the savings patients see from reduced co-payments, said Matt Walsh, associate vice president of purchaser initiatives at Health Alliance Plan, a health insurer owned by Henry Ford.

Royal Oak's Dr. David Allard was one of the first Henry Ford doctors to use ePrescribing. His office has had electronic medical records for years, but had relied on pen and paper for prescriptions until January 2005. He says his staff saves a lot of time that used to be spent on the phone with pharmacies handling prescription refills and questions on scripts. "That was hours a day in my office," he said.

But more importantly, he sees the benefit in reducing the potential for errors. Refilling prescriptions, for example, involved a lot of hand-offs between staff members and interaction with pharmacies. With each step came a chance for a mistake.

Handwriting kills
More attention is being focused nationally on drug errors and how to avoid them. According to an Institute of Medicine report issued last year, drug errors kill 1.5 million Americans each year. The report said eliminating handwritten prescriptions is the most vital step health care providers must take to cut down on errors, and recommended that all prescriptions be written electronically by 2010.

The institute is a branch of the National Academy of Sciences, an independent adviser to the government on scientific issues.
Allard's patient Susan Smith said she appreciates saving money with generic alternatives that ePrescribing has brought up during her office visits. She loves the convenience of ePrescribing even more.

Because the script goes directly to the pharmacy, she doesn't have to wait to pick it up. "It's so much more efficient," she said. "My time is real precious to me."

For outside observers, the ePrescribing effort is laudable. "It not only reduces costs but improves the quality of care by reducing drug interaction," said Eileen Ellis, principal of Health Management Associates, a Lansing-based consulting firm.
Recognizing the benefits of electronic records, health systems across southeast Michigan have been spending millions to install electronic medical records.

But doctors' offices have lagged because of the cost, which can be in the tens of thousands and more for a practice.
At about $2,000 a doctor to implement, ePrescribing is much less expensive, but is nevertheless a step in that direction. The coalition helps participating doctors with a $1,000 subsidy.

"This is a great way to get technology into the doctor's office. It's not real expensive; it's fairly easy to adopt," Walsh said.

Thursday, November 1, 2007

November is National Caregiver's Month

To celebrate, go care for someone or give a caregiver the day off!

Exelon Follow-up

October 23rd 2007 was the first day that the Exelon transdermal patch, the first and only skin patch for the symptomatic treatment of mild to moderately severe Alzheimer's dementia, is available in the UK market. Here's some info on it from, no author given:

A clinical study of 1,195 people with Alzheimer's dementia demonstrated that the rivastigmine patch improves cognitive function (assessed using a tool that includes measures of orientation, memory and language), as well as a patient's ability to perform everyday activities compared to placebo. The study also showed that the 9.5mg/24h patch is as effective as the maximum titrated dose of rivastigmine oral capsules.

Applied once a day (replaced every 24 hours), the rivastigmine patch provides smooth and continuous delivery of rivastigmine through the skin, which reduces nausea and vomiting caused by peaks in medication levels when the drug is taken orally.
Dr Peter Connelly, Consultant in Old Age Psychiatry, Perth, Scotland comments, "The Exelon patch represents a valuable advance in the treatment of Alzheimer's disease. This formulation offers patients and their carers an effective, well-tolerated and convenient therapy option. I expect a significant proportion of carers will find the patch easier to use compared to the conventional formulation."

Family cargivers are the backbone of long-term care to Alzheimer's disease patients, frequently responsible for administering and managing patient medication. A survey conducted in over 1,000 caregivers showed that more than 70 per cent preferred the patch as a method of drug delivery compared to oral capsules(3). The most common reasons for preferring the patch were ease of following the schedule and ease of use.

The rivastigmine patch can be applied to the upper arm, chest or back(4). The patch may allow those caring for Alzheimer's disease patients to monitor treatment compliance because it provides visual reassurance that the medication has been taken. Compliance with prescribed medication regimens represents a challenge for most patients but may be particularly difficult for older people due to: the extent to which drug regimens interfere with daily living; lack of understanding or misinterpretation of instructions; complex and complicated drug regimens; and forgetfulness(6). 75% of older people are believed to not comply with their treatment regimens.

"Caring for a relative with Alzheimer's is very time-consuming and sometimes overwhelming. There's a lot to think about and sufferers are often on a number of medications," comments carer Lisa, who used to look after her sister at home. "People with the disease can find it difficult to take oral medication and to comply with a strict routine. A patch that provides 24 hour cover could help keep track of when medication has been taken."

I'm all for anything to improve patient medication adherence. Once again my hope is that patients remember they have the patch on and rmember to change them as well. To celebrate National Caregivers Month - here's to Novartis!

Wednesday, October 24, 2007

Older is Wiser

From Science Daily dated 08.19.98 - just found randomly.

Remembering Your Medications: Older are Wiser

"Being too busy, not being old, is what leads people to make mistakes in taking their medications," says Denise C. Park, a psychologist at the U-M Institute for Social Research who presented her findings this month at the annual meeting of the International Congress of Applied Psychology.

As the population ages, the problem of forgetting to take the pills your doctor ordered--the right number of the right kind at the right times--will affect more and more people who are trying to manage diabetes, depression, high blood pressure, arthritis and other chronic age-related conditions.

According to Park, the conventional view has been that as patients age, their medication adherence rates drop, just when their need to manage complicated medication schedules increases.

With funding from the National Institute on Aging, Park and colleagues carried out a study designed not only to learn who really is most likely to make mistakes, but also what kinds of errors occur and why they're being made.
For eight weeks, the researchers studied 121 men and women between the ages of 34 and 84, all diagnosed with moderately severe rheumatoid arthritis.

"We selected that illness because we expected medication adherence to be very good," says Park. "Taking the medications commonly prescribed leads to real relief from pain, stiffness, and other symptoms. And that gives people a strong motivation to take medications on schedule." Participants in the study took four types of medication, on average.

At the start of the study, researchers tested all the participants to determine their levels of depression and anxiety, and to see what their attitudes were about arthritis and disease in general. They also asked how helpful participants thought it was to take the specific medications they had, and medications in general. Participants also went through a range of tests assessing their memory, recall and other measures of mental functioning.

Park and her colleagues developed the "Busy Life Style Questionnaire," to measure the chaos and unpredictability in the daily lives of participants. Among the items were questions asking how often you have too many things to do each day to get them all done, how often you're so busy that you miss scheduled breaks or rest periods, or stay up later than normal, and how often you follow other regular routines, including eating meals at about the same time each day, or engaging in regular activities at home, such as reading the paper, watching a particular television show, or talking with family members.
After these initial assessments, participants received the prescriptions they were taking in new containers, special bottles with caps containing tiny electronic monitoring chips that recorded exactly when the bottles were opened.

After eight weeks, all the participants turned in the new containers. The information in the bottle-cap chips was downloaded into a computer file and analyzed.

Overall, the researchers found a surprisingly high level of adherence. Nearly 40 percent of participants didn't make a single medication error during the two months studied. Of all the mistakes that were made, more than 98 percent were errors of omission; only 1.2 percent took an extra dose.

Perfect adherence was more common among older than younger adults, Parks found. Fully 47 percent of those over the age of 55 made no mistakes, compared with only 28 percent of those between the ages of 34 and 54.

What usually led to mistakes was being too busy, Park notes. Being slightly unhappy also contributed, combined with the belief that taking the medication as prescribed may make you feel better physically but won't make you feel any better emotionally.

"Being a very busy person is the single biggest risk factor we found," says Park. "Having a life that's overly full leaves little time to attend to health concerns."

For doctors, the implications of the research are clear. "Consider prescribing simpler drug regimens for busy, middle-aged patients, not for older patients," says Park.

For middle-aged people too busy to take care of their health by remembering to take their medications on time, Park suggests using memory aids like written reminders or beeping wristwatches.

Tuesday, October 16, 2007

Lamotrigine XR Proven Effective for Epileptics - GSK funded Study

I found this on a couple of sites but liked this MedScape article the best. One thing I do not understand about epileptics and patients with chronic illnesses in general is why they do not take their medications knowing the results. One of my friends in epileptic, something that I had forgotten until the day after another friend's wedding. She had a seizure at the Sunday brunch. This was a fit I had never seen and it was quite scary for all of us there, and can only imagine the effect on her. I am pretty sure it was a result of her non-adherence to her medication. Luckily many of her friends were there who had experienced her seizing before so they knew how to treat her.

As with all XR drugs, they aim to improve medication adherence, yet pharmaceutical companies usually start developing and testing XR fomulas when their patent is close to expiration. I am all for medication adherence (as we know) however why wasn't this the first drug to be released? Hey, we spent $800M on a drug and sold it for 6 years, but here is a better version because a generic is now available for the first version and we want to make more money and keep you as a patient. Yes, I know the answer and it always be the case until we are in the future world where all medications are free, have no side effects, and there is no global warming, polution, etc....

Just for fun, see who funded the study and who employs the MDs at the end.

October 15, 2007 — Once-daily adjunctive lamotrigine extended-release (XR) was effective in controlling partial seizures, according to the results of a double-blind, placebo-controlled, randomized trial reported in the October 15 issue of Neurology.

"The goal of enhancing dosing convenience and thereby compliance has motivated the development of lamotrigine extended-release (XR), an enteric-coated, slow-release formulation," write D.K. Naritoku, MD, from Southern Illinois University in Springfield, and colleagues. "Whereas conventional immediate-release (IR) lamotrigine tablets are recommended for twice-daily dosing when used with enzyme-inducing AEDs [antiepileptic drugs] or as monotherapy and for once- or twice-daily dosing when used with valproate, the pharmacokinetic properties of lamotrigine XR make it suitable for once-daily dosing in epilepsy regardless of concomitant AED."

In this parallel-group trial, 243 patients older than 12 years diagnosed with epilepsy with partial seizures and taking 1 to 2 baseline antiepileptic drugs were randomized to adjunctive once-daily lamotrigine XR or placebo. After the baseline phase, 239 patients entered a 7-week, double-blind escalation phase. During the 12-week, double-blind, maintenance phase, doses of study medication and concomitant antiepileptic drugs were maintained.

Of the 239 patients who entered the escalation phase and received study medication, 118 received lamotrigine XR, and 121 received placebo. Compared with placebo, lamotrigine XR was more effective in terms of median percent reduction from baseline in weekly partial seizure frequency (primary endpoint, entire 19-week treatment phase: 46.1% vs 24.2%; P = .0004; escalation phase: 28.0% vs 16.3%; P = .028; maintenance phase: 58.0% vs 26.7%: P < .0001).

The percentage of patients with at least a 50% decrease in frequency of partial seizures (42.2% vs 24.2%; P = .0037) and time to 50% or more reduction in partial seizure frequency (P = .0007) also favored lamotrigine XR over placebo. For secondarily generalized seizures, findings were comparable.

The most frequently reported adverse events were headache (17% with lamotrigine XR vs 15% with placebo) and dizziness (18% with lamotrigine XR vs 5% with placebo). Health outcome measures were not significantly different between groups. There were no serious rashes, and laboratory test results and electrocardiogram findings were unremarkable in both groups.

"Once-daily adjunctive lamotrigine extended-release compared with placebo effectively reduced partial seizure frequency and was well tolerated in this double-blind study," the authors write. "Results support the clinical utility of this new once-daily formulation."

Study limitations include small sample sizes for end-of-study health outcomes questionnaires, with resulting low power for detecting treatment differences.

GlaxoSmithKline, the maker of lamotrigine, sponsored and conducted this study, employs 2 of the authors, funded 1 of the authors, and has various financial relationships with 2 other authors.

Thursday, October 11, 2007

Topamax to Cure Alcoholism and Binge Drinking

Found information on the JAMA article and study in many different media outlets. This is from FirstWord and hits the high notes. I find it very funny that one of the side effects was migranes. The average drinker went from 12 drinks to 8 a day. To me, 12 drinks is a lot to manage in a day. Also that it helps with withdrawal makes sense since it is a treatment for epilepsy and a major part of withdrawal is the shakes!

Also below is the JAMA abstract for those who are interested.

Study: Johnson & Johnson's Topamax may help reduce alcohol dependency
by Alison Fischer
Study results demonstrated that more heavy drinkers who received Johnson & Johnson's Topamax (topiramate) quit drinking by the end of the trial, compared with those who received placebo, according to findings published in the current issue of JAMA.

The company-sponsored, 14-week study enrolled 371 men and women who were heavy drinkers. About half the participants received placebo, and half Johnson & Johnson's drug. The findings showed that 27 of 183 patients taking Topamax stopped drinking by the end of the trial, compared with 6 of 188 patients given placebo. The data also demonstrated that Topamax was more effective at reducing the percentage of heavy-drinking days, compared with placebo.

The drugmaker indicated that it does not plan to conduct further testing or seek FDA approval for Topamax as a treatment for alcohol dependency. Nonetheless, in an editorial accompanying the study, Mark Willenbring, a director at the National Institute on Alcohol Abuse and Alcoholism, stated that "we now have very high-quality evidence that shows efficacy. The medical world doesn't wait for the indication."

However, Sidney Wolfe, director of the Health Research Group at Public Citizen, raised concerns that a press kit about the study from the University of Virginia promoted use of Johnson & Johnson's drug as a treatment for alcoholism. Wolfe asked the US regulatory agency to stop an "illegal and dangerous promotional campaign'' linked to the study, adding that "it is not the research or the publication of the study that is illegal but the promotional material that goes beyond the research to solicit new sales for the drug."

A spokesperson for Johnson & Johnson commented that company "does not support any reference to off-label use of our products. We only promote the use of Topamax for the approved indications of migraine prevention and epilepsy."

JAMA Abstract
Context: Hypothetically, topiramate can improve drinking outcomes among alcohol-dependent individuals by reducing alcohol's reinforcing effects through facilitation of -aminobutyric acid function and inhibition of glutaminergic pathways in the corticomesolimbic system.

Objective: To determine if topiramate is a safe and efficacious treatment for alcohol dependence.

Design, Setting, and Participants: Double-blind, randomized, placebo-controlled, 14-week trial of 371 men and women aged 18 to 65 years diagnosed with alcohol dependence, conducted between January 27, 2004, and August 4, 2006, at 17 US sites.

Interventions: Up to 300 mg/d of topiramate (n = 183) or placebo (n = 188), along with a weekly compliance enhancement intervention.

Main Outcome Measures: Primary efficacy variable was self-reported percentage of heavy drinking days. Secondary outcomes included other self-reported drinking measures (percentage of days abstinent and drinks per drinking day) along with the laboratory measure of alcohol consumption (plasma -glutamyltransferase).

Results: Treating all dropouts as relapse to baseline, topiramate was more efficacious than placebo at reducing the percentage of heavy drinking days from baseline to week 14 (mean difference, 8.44%; 95% confidence interval, 3.07%-13.80%; P = .002).

Prespecified mixed-model analysis also showed that topiramate compared with placebo decreased the percentage of heavy drinking days (mean difference, 16.19%; 95% confidence interval, 10.79%-21.60%; P < .001) and all other drinking outcomes (P < .001 for all comparisons).

Adverse events that were more common with topiramate vs placebo, respectively, included paresthesia (50.8% vs 10.6%), taste perversion (23.0% vs 4.8%), anorexia (19.7% vs 6.9%), and difficulty with concentration (14.8% vs 3.2%).

Conclusion: Topiramate is a promising treatment for alcohol dependence.

Tuesday, October 9, 2007

Achtar Price to Go up to $23,000 a Vial

This just strikes me as wrong, and is going to have a huge impact on adherence. From the Philadelphia Inquirer.

PHILADELPHIA _ There's one drug most doctors turn to first when babies have catastrophic seizures: a natural hormone sold under the name H.P. Acthar. It's the gold standard to stop seizures that can ruin a child's chance for a normal life.

On Aug. 27, the lone maker of that drug raised the price from $1,650 a vial to more than $23,000 a vial, sending the price for an average patient to $100,000 or more.

The 14-fold increase stunned some caregivers and seemed to crystallize their frustrations over drug pricing.

"It's an obscene increase. I could almost see doubling or tripling the price but (14) times seems ridiculous," said Sarah Erush, clinical manager of pharmacy at the Children's Hospital of Philadelphia.

Robert R. Clancy, a neurologist who directs the hospital's Pediatric Regional Epilepsy Program, said, "Everyone understands it's a business and they need to have a fair profit. But to go from $1,600 to $23,000 strikes me as old-fashioned greed."

The maker, Questcor Pharmaceuticals Inc. of Union City, Calif., says it had no choice. The company, which has been losing nearly $1 million a month receives more than 90 percent of its revenues from Acthar. It had $12.8 million in total revenues last year.

"We had to take this kind of a pricing increase to insure that Acthar remains available," said Steve Cartt, Questcor's executive vice president for corporate development. "The company was in a bad situation."

Cartt said the firm has revamped a patient assistance program to make more Acthar available at no cost to help uninsured parents, and it has started two copay assistance programs.

But the price hike has already caused at least one insurer to put in a more stringent pre-authorization process. Experts say it's likely that many patients will find it harder to get this drug.

The increase is an extreme example of how drugs are priced in the United States: There is no regulation of drug prices. Companies can charge what the market will bear, and commercial insurers, who cover most employees' prescriptions, often follow Medicare's lead in covering drugs.

Prescription drugs are "a legal monopoly. We expect monopolists to behave like monopolists," said Mark V. Pauly, a health economist at the Wharton School. "The argument is the higher profits will stimulate further beneficial research."

Large spikes in drug prices are not uncommon, especially when the potential market is small.

In 2006, Ovation Pharmaceuticals raised the price of indomethacin, an injected anti-inflammatory drug often used in premature babies, from $100 to $1,875 for three vials, prompting howls of protest. "This is a rather astounding increase in price for a drug that has a stable niche market and requires no advertising," declared Alan H. Jobe, a doctor at Cincinnati Children's Hospital, in the journal Pediatrics.

Ovation spokeswoman Sally Benjamin Young said the drug, which privately-held Ovation acquired from Merck & Co. Inc. in 2006, had had few price adjustments since it was introduced in 1985. The hike was needed to support better testing, packaging and manufacturing, and to insure a more stable supply, she said.

Experts say it's not uncommon for new drugs, especially for rare diseases, to cost more than $100,000 a year. The high price is needed, economists say, so the firm can be encouraged to enter the field.

What sets apart Acthar is that it's a very old drug. The compound (Adrenocorticotropic hormone) was first synthesized in the 1940s by Armour & Co., the canned meat firm, which harvested it from pigs' pituitary glands.

The drug, used for years to treat Infantile Spasms, was made by Rhone-Poulenc Rorer and then by its successor, Aventis. It was never a big seller, and the former owner nearly stopped making it in the mid-1990s _ only to see it brought back after a storm of pediatricians complained that there was no substitute.

Questcor bought the rights to the drug in 2001. The company sought formal approval for Infantile Spasms from the Food and Drug Administration, but it issued a "non-approvable" letter in May. The agency didn't think the existing clinical trials were good enough, Cartt said, adding that the firm is exploring what kind of tests the FDA will need.

Even without formal FDA approval, Acthar remains the drug of choice for babies with Infantile Spasms. It's the most likely drug to end the seizures, which, if unstopped, make the chances of normal development remote at best.

Acthar is also one of several drugs that helps with sudden flare-ups in multiple sclerosis patients though its use is small.

FDA To Hire More Staffers for Generic Application Processing

I just thought this was interesting. Off the AP Wire.

WASHINGTON_The Food and Drug Administration on Thursday unveiled a plan to speed up the approval of generic drugs and address a backlog of hundreds of applications.

FDA officials outlined a half dozen recent changes that it said will streamline how the agency processes applications for cheaper versions of branded drugs.

Perhaps most significantly, FDA said it would immediately begin processing applications for generic drugs that have lost patent protection. Previously these applications would sit in a queue behind applications for drugs that might still be patented for years.

FDA also said it hopes to hire additional employees beyond the 215 staffers who currently review generic drug applications. Whether FDA has funding to hire new reviewers depends on whether Congress approves the agency's budget request later this year.

Unlike makers of traditional drugs, generic drug companies do not pay user fees to help offset the cost of hiring drug reviewers. Efforts to set up generic drug user fees have been opposed by the Generic Pharmaceutical Assocation, whose members include Barr Pharmaceuticals Inc., Mylan Laboratories Inc. and Teva Pharmaceutical Industries Ltd.

The industry group reacted coolly to FDA's initiative, saying the best way to speed up generic drug approvals is to outlaw tactics which branded companies use to protect their drug patients.

"For years, the agency has tinkered around the edges with programs and initiatives designed to increase efficiency but have proven to yield little in the way of significant results," said Kathleen Jaeger, the group's president. "There are serious legislative and regulatory issues that must be addressed to yield a true increase in the number of affordable generics brought to market."

Aclasta Gets EU Approval

Just a quicky from PharmaLive. This should really improve adherence - if they go to the MD on time!

Switzerland's Novartis AG said today the EU has approved Aclasta the first once-yearly treatment for women with postmenopausal osteoporosis. The drug was approved by the FDA in August under the name of Reclast. Last month a study showed the drug used by elderly patients who have had a hip fracture reduced deaths by 28 percent and new fractures by 35 percent over a two-year period.

Friday, October 5, 2007

Beliefs about medicines and self-reported adherence among pharmacy clients.

Below is an abstract I can across this morning. Unfortunately I am traveling to the memorial service for the great American poet, William Meredith, at my alma mater and do not have the time to read or research everything today. Just wanted to give you a clip of some interesting work - although (again) it is self-reported, the numbers are more in line with the average.

Department of Public Health and Community Medicine, Göteborg University, Box 453, SE-405 30 Göteborg, Sweden.
Beliefs about medicines and self-reported adherence among pharmacy clients.

OBJECTIVES: To analyse any association between general beliefs about medicines and self-reported adherence among pharmacy clients. Further, to examine general beliefs about medicines by background variables.

METHODS: The data were collected by questionnaires including the general section of the Beliefs about Medicines Questionnaire (BMQ), the self-reporting Medication Adherence Report Scale (MARS) and the following background variables: gender, age, education, country of birth and medicine use. The General BMQ measures beliefs about medicines as something harmful (General-Harm), beneficial (General-Benefit) and beliefs about how doctors prescribe medicines (General-Overuse).

RESULTS: Of the 324 participating pharmacy clients, 54% were considered non-adherent. An association was found between General-Harm and adherence. Adherent behaviour and higher level of education were associated respectively with more beneficial and less harmful beliefs about medicines. Those born in the Nordic countries regarded medicines as more beneficial. Current users of herbal medicines and non-users of medicines were more likely to believe that doctors overprescribed medicines.

CONCLUSIONS: General-Harm was associated with adherence to medication among Swedish pharmacy clients. Country of birth, education and medicine use influenced beliefs about medicines.

PRACTICE IMPLICATIONS: Increased awareness of the patient's beliefs about medicines is needed among healthcare providers. We should encourage patients to express their views about medicines in order to optimize and personalize the information process. This can stimulate concordance and adherence to medication.

Thursday, October 4, 2007

Half of Hypertensive CA Adults Take Drugs for Blood Pressure

This is a press release from the American Heart Association. I have been at a conference this week, but wanted to post this information. My comments will come at a later date.

About half of California adults diagnosed with high blood pressure, or hypertension, do not take medication to lower it, researchers reported today at the American Heart Association’s 61st Annual Fall Conference of the Council for High Blood Pressure Research.

Of those who do, regularly seeing a doctor makes a big difference in their medication adherence.

In a study of California adults, of 42,044 respondents, 11,467 of them said a doctor had told them they had high blood pressure. When adjusted for age, this yielded a prevalence rate of 24.5 percent.

Researchers also found, on an age-adjusted basis, that 49.4 percent of those diagnosed with hypertension, a potentially life-threatening disease, were not taking drugs to lower it. People who had seen a physician during the prior year were more than five times more likely to be on medication than were those who had not.

“That was informative,” said David J. Reynen, M.P.P.A., M.P.H., lead author of the study. “It really underscores the importance of having routine care.”

High blood pressure is a major risk factor for heart attacks and strokes, and it increases a person’s risk of heart failure, kidney disease and blindness.

Doctors recommend drug treatment when a person’s blood pressure consistently measures 140/90 millimeters of mercury (mm Hg) or higher.

Reynen and his colleagues at the California Department of Public Health’s Heart Disease and Stroke Prevention Program in Sacramento wanted a clearer picture of high blood pressure in their state. They proposed a series of questions to be included in the California Health Interview Survey, which is conducted by telephone every two years, and then analyzed the results.

“Unfortunately, the data are collected in such a way that we don’t know to what degree the individual respondents have hypertension,” Reynen said. “One in four adults in California, including one in three African Americans, is hypertensive,” he said. “We talk about people needing to know their numbers. That means not just whether your blood pressure is high or low, but your actual numbers. This study reinforces that.”

The researchers used age-adjustment to standardize the survey results so they could more accurately compare various groups.

Among those surveyed with high blood pressure, the analysis showed that the age-adjusted odds of a person taking drugs to lower blood pressure are:

5.23 times higher for people who saw a physician within the past year compared to those who did not;
2.47 times higher for those with diabetes than those without the disease;
2.05 times higher for those who had health insurance than those who did not;
1.71 times higher for African Americans than for whites (the racial/ethnic groups, respectively, with the highest and lowest high blood pressure rate);
1.46 times higher for people who described their health as poor or fair compared to those in good health;
1.40 times higher for patients diagnosed with heart disease than those without it;
1.38 times higher for smokers than nonsmokers;
1.27 times higher for U.S.-born individuals than foreign-born;
1.21 times higher for people with some form of formal education after graduating high school than those with less formal education.

“Understanding these factors may allow us to develop better strategies to increase the use of blood-pressure-lowering drugs among those with high blood pressure,” Reynen said.

The age-adjusted prevalence of high blood pressure and drug treatment sometimes varied considerably among the various groups surveyed:

African Americans had the highest prevalence of high blood pressure (35 percent), followed by American Indians (29.8 percent), Pacific Islanders (27.2 percent), those of other race/ethnicity (25.9 percent), Latinos (25.0 percent), Asians (24.5 percent) and whites (23.1 percent).

African Americans had the highest rate of drug use to control their high blood pressure (56.6 percent), followed by American Indians (53.1 percent), Asians (52.1 percent), Pacific Islanders (52 percent), whites (49 percent), Latinos (45.8 percent) and those of other race/ethnicity (44.4 percent).

“Physicians should be mindful of these kinds of associated factors when developing treatment plans, and public health officials should be mindful of them when developing public health interventions,” Reynen said. “Knowing someone’s racial/ethnic group may be helpful to us when we try to target messages to this population to tell them they need to see a physician if they have high blood pressure.”

Friday, September 28, 2007

New Weapon for Flu Pandemic: Jello Shots Up Your Nose!

This article is from US - PharmaTechnologist. No real comments save I think this is pretty neat. It will definately help with flu shots, as a number of people hate needles. It could be kind of gross however, if the jelly stays to long! Everyone laughed at me in college, but I knew investing in an aloe vera farm would pay off one day!

No wobbles for jelly nasal spray vaccine
By Katrina Megget

9/27/2007 - It is not the same as jellied pig's trotters, but a jelly nose has the 'exciting potential' to be the next weapon in the arsenal against pandemic flu.

Researchers at Texas A&M University, in conjunction with DelSite Biotechnologies, are working on a pandemic flu vaccine based on a powder nasal spray that forms a jelly in the nose.

While still at animal trial level, studies have so far shown the jelly substance that forms in the nose after spraying keeps the vaccine antigen in the nasal passage for longer giving the immune system a greater and prolonged stimulus.

"When this powder vaccine is puffed into the nose, it forms a jelly-like substance that clings to the inside of the nose and is absorbed into the body much more effectively. It stays longer and it has more time to do its work," Texas A&M University College of Veterinary Medicine and Biomedical Sciences pathobiology professor Dr Ian Tizard said.

The vaccine is formulated using an undisclosed carbohydrate from the Aloe vera plant which is mixed with the vaccine component and dried together to form a powder.

On contact with the moisture of the nasal passage, the powder is reconstituted; dissolving the product and interacting with the carbohydrate to form a jelly.

"This powder form is more effective than a liquid spray because the nose tends to clear liquid sprays out, while the powder turns into a sticky gel and can be a much more potent vaccine," Tizard said.

One or two puffs into the nose was all that was needed to get results. The length of time the jelly would stay in a human nose was currently unknown.

The unique Aloe vera carbohydrate was yet to be approved as an excipient in the vaccine, but meetings with authorities were expected next month to discuss the ingredient, Tizard told

The carbohydrate is extracted from the leaves of the Aloe vera through a number of extraction steps thereby removing the other beneficially therapeutic compounds the plant is famous for.

"There is no other evidence the carbohydrate has any other effect other than reducing clearance from the nose," Tizard said.

Besides being retained in the nose for longer in the jelly form, the vaccine had other benefits Tizard said, including being a needle-free vaccine, being formulated as a dry powder which was more stable and could be stored for longer, and showing "significant dose sparing relative to other intranasal vaccines" without the use of an adjuvant.

The vaccine was currently being developed for pandemic bird flu, but Tizard said the technology could work to develop vaccines for other diseases.

"The plan was to try this first as a vaccine for bird flu in humans because there was an immediate concern there, and there still is the possibility that a widespread bird flu epidemic could break out somewhere in the world. But there is no reason to think this method of vaccine treatment would not work for many other diseases too. We think it's an exciting breakthrough that has great potential," Tizard said.

While the development of the vaccine was still early, tests on humans were expected to begin next year.

MedImmune has had its liquid nasal spray flu vaccine, FluMist, on the market since 2003, which was the first needle-free flu vaccine available on the market, and the company is developing a next generation nasal mist flu vaccine.

The nose jelly project is funded in part by a $6m grant from the National Institutes of Health awarded to DelSite Biotechnologies in conjunction with the Texas A&M teams.

Monday, September 24, 2007

Quotes from Heart and Soul Researcher

Here is a little follow-up to my post on 9.17.07 regarding the Heart and Soul Study. Here are some quotes from the researcher Dr Anil K Gehi from Emory University School of Medicine, Atlanta, GA. These quotes are from an article on the website by Lisa Nainggolan 9.24.07:

"We've shown that simply asking the patient whether they were adherent to their medication is a pretty decent way to identify those patients we might need to focus on," Gehi told heartwire.

"The bottom line is that medication nonadherence is a big predictor of adverse cardiovascular outcomes, and we found that the risk associated with nonadherence was equivalent to that associated with diabetes or smoking. Nonadherence is really a big deal that a lot of physicians don't look at carefully, and it's not a difficult thing to find out."

"We have shown that it's not a difficult thing to find out about adherence, but this is something that perhaps physicians overlook. Our study helps emphasize how important it is; then, something can be done about addressing the specific issues relating to adherence with that patient."

Those who are found to be nonadherent can be targeted with a number of approaches; Gehi suggests such strategies as pillboxes, getting family involved in medication, and arranging more frequent follow-up visits.

"Also, sometimes simply explaining to a patient what a pill is for and the importance of that medication can make a big difference.".

Uh, duh? I am greatful that this study was done to show how important medication non-adherence is to the world (also highlighted in the NCPIE study, and the WHO Study, countless articles, and this blog). But again, come on, if you don't take your pills you are not going to be healthy. Plain and Simple.

EU Approval for Exelon

I have writen about patches in the past - both pro and con. With the EU approval of Exelon, caregivers and patients with Alzheimer's have reason to cheer for better medication adherence. I can only imagine how difficult it must be to care for a parent or spouse with Alzheimer's - not to mention their medication regime. Hopefully the Exelon patch will have a successful launch and adoption in the EU.

The Exelon patch was approved in the US in July and some expect sales to reach the $1B mark.

Here is a blurb from 9/24 Nursing In Practice website, no author provided:

The European Commission has on today approved the use of a transdermal patch to deliver medicine to patients with mild-to-moderately severe Alzheimer's disease. The patch is the first type of transdermal treatment for Alzheimer's disease and is applied once a day to the back, chest or upper arm of patients.

Experts say the patch improves compliance for Alzheimer's patients and also reduces side-effects.

"All these benefits offer the potential for improved outcomes in patients," said James Shannon, global head of development at Novartis Pharma.

"Exelon patch represents a therapeutic innovation that is designed specifically to meet the needs of patients, caregivers and physicians involved with this devastating disease."

Bruno Dubois, Professor of Neurology in Paris, France, agrees that the patch provides vital reassurance that patients have "taken" their medicine, adding: "Just having to apply a patch can help reduce the burden of family life for people with Alzheimer's disease and their families."

In a survey of Alzheimer's caregivers, 70% said they preferred the patch to oral medicines as it helped them follow their treatment schedules and was easier to use.

"People with Alzheimer's disease and their caregivers welcome every new therapy for the disease," said Mark Wortmann, executive director of Alzheimer's Disease International. "I am pleased that the patch offers a new approach to treatment."

Rare Blood Disease

On a personal note, I was diagnosed with a rare blood disease this morning. Unfortunately I forgot the name of the disease but will post again later when I know more about it. Perhaps start a new blog. It has something to do with a build up of iron in the blood.

I do not necessarily have this disease, but I have one of the genes that patients of this disease have. My MD mentioned homo and hetero genes - I have one but not two. It is something he wants to monitor every three months or so.

Point being: my doctor said this disease is fatal, but easily treatable - I just have to give a pint of blood twice a year or so.

Thus what should I do? Be non-adherent and DIE, or go to the doctor and extra two times a year and let him take some blood?

Tough question.

If there was two of me - based on the national non-adhrence numbers - one would die and the other would live.

I think I will choose to live.

Monday, September 17, 2007

Heart and Soul Study

Below is the Abstract from the Heart and Soul Study I found in The Archives of Internal Medicine current issue. Unfortunately I do not have a subscription, but I can see flaws in this study just looking at the methodology. I support studies like this in finding the root and causes of medication non-adherence, but self reporting has never been an acurate measure. See my comments below.

Nonadherence to physician treatment recommendations is an increasingly recognized cause of adverse outcomes and increased health care costs, particularly among patients with cardiovascular disease. Whether patient self-report can provide an accurate assessment of medication adherence in outpatients with stable coronary heart disease is unknown.

We prospectively evaluated the risk of cardiovascular events associated with self-reported medication nonadherence in 1015 outpatients with established coronary heart disease from the Heart and Soul Study. We asked participants a single question: "In the past month, how often did you take your medications as the doctor prescribed?" Nonadherence was defined as taking medications as prescribed 75% of the time or less. Cardiovascular events (coronary heart disease death, myocardial infarction, or stroke) were identified by review of medical records during 3.9 years of follow-up. We used Cox proportional hazards analysis to determine the risk of adverse cardiovascular events associated with self-reported medication nonadherence.

Of the 1015 participants, 83 (8.2%) reported nonadherence to their medications, and 146 (14.4%) developed cardiovascular events. Nonadherent participants were more likely than adherent participants to develop cardiovascular events during 3.9 years of follow-up (22.9% vs 13.8%, P = .03). Self-reported nonadherence remained independently predictive of adverse cardiovascular events after adjusting for baseline cardiac disease severity, traditional risk factors, and depressive symptoms (hazards ratio, 2.3; 95% confidence interval, 1.3-4.3; P = .006).

In outpatients with stable coronary heart disease, self-reported medication nonadherence is associated with a greater than 2-fold increased rate of subsequent cardiovascular events. A single question about medication adherence may be a simple and effective method to identify patients at higher risk for adverse cardiovascular events.

I don't really like the number 75% as being a proper number for adherence. It should be 100%. Diabetics need to take their pills everyday or suffer problmes with their blood sugar. What if they only chose to take those pills five days a week and skip the weekend? Does that 75% sound OK to you?

Here's a surprising fact: if you do not take your medication, you are more than likely to have a heart attack. The national average for non-adherence is over 50% - it is astounding how they found the minority as the basis for their study. As far as I know, self reporting has never been an acurate gauge for a study.

Everyone feels guilty and will lie regarding non-adherent behavior regarding everything from flossing to diet to heart medication. Here, take these, they will save your life - oh jeez, yeah I know I was supposed to take them, but, you know, I forgot, so now I am in the hospital - but I did tell you I took them.

Patient education is an important factor, as well as side effects and financial costs when dealing with medication non-adherence. But most often, people forget and it is not in their behavior (especially with a new script) to be adherent to medication - although in this case I like compliant because if you do not take that medication, you will return the hospital and die.

Wow I hit the 500 Mark!!!!

I am very excited for myself and hope that the people who have read this blog have learned more about medication adherence and realize it is a serious problem that needs to be addressed. $177 BILLION can be saved - well probably not all of it, but a fair amount can be saved if patients would properly take their medications as prescribed and caregivers have the means to properly medicate their wards.

The real number is probably a lot less as I visit my blog at least 10 times a week - and the counter has been up since July 10th - so that is about 115 visits by me alone!

In any case, I am here to inform and help if I can.

Stay adherent!

Insulin Pen

This little blurb from KHTS Radio AM 1220, a Santa Clarita CA radio station. I do not have much to say about this at the moment, other than sounds good! I will look into this some more.

The new insulin pen, which was made available this month, combines the insulin cartridge and syringe in a single unit, making regular use more convenient, which doctors say decreases claims of hypoglycemic episodes, emergency room and physician visits, and overall treatment costs.

“The pen is a huge, huge benefit in the treatment of diabetes,” said Reza Bonabi, M.D., a Diabetalogist and chairman of the diabetes committee at Providence Holy Cross Medical Center. “The pen will reduce dosage error, is easy to administer, and will decrease the cost of treatment for both the hospital and patient.”

Won Chan Lee, Ph.D., Abbott Laboratories’ Associates Director of Health Economics, studied the effects of the new device. "As evidenced by the marked improvement in medication adherence rates, patients who switched to the insulin pen found that its convenience and ease of use gave them a new ability to self-manage their condition and a resulting freedom from complications and visits to the emergency room,” Lee said.

“But our study also demonstrated a true 'win-win' situation, for individuals with diabetes and for society as a whole, due to significant decreases in the costs associated with hypoglycemic events — events that can be kept at a manageable level or avoidable, as long as a patient adheres to his or her treatment."

Hospital employees also are less at risk at being pricked by a needle when using the pen to provide insulin to the patients, said Donna Ryan, Diabetes Department Coordinator at Providence Holy Cross Medical Center

Friday, September 14, 2007

ePrescribing in Mississippi

You don't really think of Mississippi as being an early adopter of technology, but this article on, states otherwise. My comments are below.

E-prescribing PDAs save millions for Mississippi Medicaid BY Nancy Ferris

Mississippi’s Medicaid program is saving about $1.2 million per month in prescription costs as a result of equipping 225 doctors with handheld e-prescribing devices.

State officials say the system not only reduces medication costs, it also increases the quality of care for patients. That's because doctors have access to patients’ recent medication histories and can avoid prescribing medicines that would interact with ones they are already taking.

In addition, doctors can find out whether patients are filling and refilling their prescriptions. This allows them to detect when patients’ continued poor health is due to noncompliance with the doctors’ treatment plans.

Prescribers who use the handheld devices write fewer prescriptions on average, state officials said, and those prescriptions are likely to cost the state less.

After 18 months of steady savings, the Mississippi Division of Medicaid is negotiating with its contractor to expand the e-prescribing program, officials said.

Besides cutting drug costs, the state is saving nearly $27,000 a month on hospitalizations avoided because the doctors are getting real-time alerts about drug interactions, they said.

The program costs the state about $35,000 per month, so the hospitalization savings come close to covering the cost of the handheld devices from Informed Decisions, based in Tampa, Fla.

Florida has launched a similar program, with comparable results.

Asked whether there was any negative aspect to the program, Mississippi officials said they knew of none.

“I can see which medications patients are taking regardless of who prescribed them. As a result, we are now able to keep comprehensive, up-to-date medication lists for all our patients,” said Dr. Kurt Bruckmeier, who cares for about 200 Medicaid beneficiaries through Pacific Physicians Services in Hattiesburg, Miss. “It has also helped identify drug abusers who would very likely have gone undetected were it not for our ability to evaluate the full scope of prescriptions they were taking.”

I think this is a fantastic program that will pay for itself over a very short time. ePrescribing and medication adherence go hand in hand - especially when it comes to refills. I am not familiar with pharmacy policy, but do they tell the MD when you do not refill a script? I don't think so. With all scripts and patient information linked up via these PDAs or hand tablets, MDs have all the info at their fingertips - as well as drug-drug interaction information to reduce ADRs.

The problems arise however when the technology fails and the MDs have no idea what is going on with the patient. I'm sure there are back-ups and colocation servers, but in Ol' Miss there could be flooding, hurricanes, fires, etc.... Also, as we have seen with Pfizer of the last couple of weeks, what happens when someone hacks into the system? Not that medical records of the elderly have that much value (no offense) but it is protected information that anyone can blast out over the internet or use to for blackmail (that might not happen but it could!).

This works into the EHRs that many tech companies, MDs and healthcare providers are trying to adopt. I like the idea, and use one on Revolution Health but at the same time I am wary about that information out there. Not that I have anything to hide, but I do not know who is looking at that information. Some techie who is performing a system analysis? They also capture what you are interested in, what medications you are on, etc.... which they can then use to market your "eyes" to advertisers.

Also health social networking sites which encourage you to sign up for chat groups and the like - all that information goes somewhere and is monetized somehow. Sorry for that little rant. These are all opt-in websites and have strict privacy policies and terms of use.

This of course would not happen with the proper EHRs and ePrescribing tools since they are covered under HIPPA and would be gross misconduct if that information was shared. So I encourage the technological advances - if you are heli-skiing in Canada and break your leg, the mountain MD with a handheld internet browser can see what meds you are on and your history of broken bones, your allergies, etc... And this makes for safe practices. Scuba diving in the Maldives and black-out from NO2 poisoning - same thing. When all medical records are computerized and on servers, it will be safer to get into an accident /life threatening situation!

Go forth Ol' Miss and show us the benefits of ePrescribing and adopt that new technology!

Abstracts Are For Dummies - Psychiatry

I have found a lot of abstracts today dealing with psychiatric non-adherence to medication: factors and solutions. Here is one of them and the link to get the full paper itself. It is a pdf freebee from Science Direct at the bottom of the post. Once I read the paper I will have more comments.

Medication adherence is crucial in psychiatry, especially for chronic disorders. Both clinician and patient share responsibility for adherence, which is rarely an all-or-none phenomenon. For psychiatric drugs, non-adherence rates are approximately 40–60%. Such non-adherence explains much of the difference between drug efficacy and effectiveness, as demonstrated by higher relapse rates in non-adherent patient groups. Thus, non-adherence impacts profoundly on clinical and economic burdens for health services. During clinical assessment, predictive factors of non-adherence should be considered, including: a prior history of non-adherence; alcohol or substance misuse or where treatment is during an asymptomatic phase.

Similarly, drug dose and formulation polypharmacy, side effects and the therapeutic relationship also affect adherent behaviour.

Psychoeducational interventions aiming to enhance adherence focus primarily on imparting knowledge, rather than on attitudinal and behavioural change, and have proved largely ineffective. Individual psychological interventions are more effective as they specifically target the patient’s beliefs and attitudes concerning the illness and medication by utilizing cognitive–behavioural or motivational interviewing techniques.

Compliance therapy combines all of these. All clinicians should routinely use simple adherence-enhancing techniques, particularly as dedicated resources for specialist interventions remain rare. Moreover, in an attempt to further reduce the adverse clinical and economic impact of non-adherence, it is imperative that patients are given the opportunity to have their personal individual perspectives adequately heard.

Wednesday, September 12, 2007

An Abstract That Makes You Go Duh

I have read a couple of interesting abstracts over the last few days but this one just struck me as a "duh, of course" finding. I am all for research in developing countries, and for studies regarding technology for health promotion and medication adherence - I mean I work for a healthcare technology company that is focused on medication adherence - BUT this study just seems a little unnecessary and the findings a little weak for me to digest. I would like to know how much it cost and who had the bright idea to do this. Was an all expense trip to Peru part of the reasoning?

I am probably just a little miffed because when I read the title I was pretty excited to see the paper - but when I read the abstract, I was disappointed. This must of been how my 6th grade teacher felt about my book report on The Old Man and the Sea: a man went fishing and caught a fish.

Here is the provisional abstract for you to decide from BMC:

Access, use and perceptions regarding Internet, cell phones and PDAs as a means for health promotion for people living with HIV in Peru

Internet tools, cell phones, and other information and communication technologies are being used by HIV-positive people on their own initiative. Little is known about the perceptions of HIV-positive people towards these technologies in Peru. The purpose of this paper is to report on perceptions towards use of information and communication technologies as a means to support antiretroviral medication adherence and HIV transmission risk reduction.

We conducted a qualitative study (in-depth interviews) among adult people living with HIV in two community-based clinics in Peru.

31 HIV-positive individuals in Lima were interviewed (n = 28 men, 3 women). People living with HIV in Peru are using tools such as cell phones, and the Internet (via E-mail, chat, list-serves) to support their HIV care and to make social and sexual connections. In general, they have positive perceptions about using the Internet, cell phones and PDA for HIV health promotion interventions.

Health promotion interventions using information and communication technology tools among people living with HIV in resource-constrained settings may be acceptable and feasible, and can build on existing patterns of use.

Pfizer Follow-up /Other Blogs

I am so behind on reading other blogs and postings that I failed to see others have written more in-depth and critical blogs about the Pfizer study I wrote about in my last post.

It has been pointed out to me that Dr. Showalter at AlignMap felt my post was "lacking in the kind of embittered cynicism characteristic of the AlignMap perspective." And by pointed out, I mean I read it on his blog.

He offers a much deeper analysis of this "study" as well as better comments on his blog dated 09.08.07: (I promise one day I will learn how create the best links and pictures and all of that).

I appreciate his experienced take on the Pfizer press release and his embittered criticism of the pharma industry spinning this study. I am slowly getting a handle on how to properly interpret the different "findings" and "studies" funded by pharmaceutical companies.

Dr. Rost also rips pharma reporters and Pfizer on his Question Authority site. This is not new for him considering he is a former Pfizer VP and whistleblower. I think he is somewhat full of himself but I will not go into right now.

There is a funny blog that started a few days ago that just rips into Rost and his QA blog, as well as his new gig as writer for BrandweekNRX - plus the blatant self-promotion of himself, the ranking of his blogs and his novels: I don't know if it is serious or not since the tone is quite funny, and the blogger himself is quite full of himself.

Self promotion is important, but to a point. When that promotion gets in the way of what you are supposedly presenting/representing in your blog/space/whatever. i.e. Question Authority, I assume, wants to question the authority of the pharma industry. There is a blurb from Fortune that says Rost is the "drug industry's most annoying - and effective - online scourge."

There is a sidebar where you can buy his novel - everyone has to make money.

His post from 9/11 is a Daily Show Clip parody. Very Funny. Then a listing of top medblogs, then a piece about a woman banned from smoking in her garden, followed by a promotion about Rost being involved in a Senate investigation regarding taxing big pharma.

9/10: Mentions he is getting suggestions to do pharma related postings on NRX and post things on his own blog for "regular readers". Followed by a map showing how America is #1 in our minds, a clip about a beer scooter, and two pieces about the best blogs.

9/8: States that is time for a change and that he is tired of pharma blogging - but has to do if for work on brandweekNRX. Then cites Pharmalot as doing a better job (which it is) of reporting real news.

9/7: A posting of a hand shadow show from YouTube.

9/6: A posting about the best pharma sites.

Doesn't this signal that it is time for Dr. Rost to put Question Authority to pasture? He could keep the url: - and just have it to promote himself.

That is my recomendation - but I have only had 450 or so visitors in 3 months - not the thousands Rost gets daily, so who really cares what I think?

To keep inline with what I present/represent: stay adherent to your medication regime - drugs don't work unless you take them.

Thursday, September 6, 2007

Pfizer Funded Study Says: Don't Stop Taking Your Lipitor!

This story was covered by many news outlets, but this reprint comes from FirstWord which is a pharma newsletter. I was really surprised that the non-adherence rates were higher for those patients that switched off the Lipitor. I would think that the patients would stop taking Lipitor or switch medications, and continue on the generic - not stop all together. Probably a little twist from Pfizer in reporting - or the generic did not prove any significant results and the Lipitor was too expensive? We all know the most common reasons for switching medication is cost - as exhibited here - and DTC advertising.

The heart attack rate really doesn't surprise me considering it is sometimes dangerous to change one's drug routine in the middle of treatment. No, I do not work for Pfizer.

Pfizer: Study results suggest switching from Lipitor to simvastatin raises cardiovascular risks
by Daniel Beaulieu

Data from an observational study suggest that patients who switched from Pfizer’s Lipitor (atorvastatin) to simvastatin experienced a 30-percent increase in the relative risk of major cardiovascular events, compared with those who remained on Lipitor, according to Pfizer. The study, which was funded by Pfizer, was presented at the European Society of Cardiology Congress and will also be published in The British Journal of Cardiology.

As part of the retrospective analysis, researchers analysed a UK database that included records on 11 520 patients who took Lipitor for at least six months between October 1997 and June 2005, including 2511 patients who were switched to simvastatin, and 9009 patients who remained on Pfizer’s drug. The findings showed that there was a 43-percent increase in the risk of major cardiovascular events including heart attacks, strokes, and certain types of heart surgeries, for those who switched to simvastatin compared with those who remained on Lipitor. However, there was no difference in all-cause death between the two groups.

A secondary analysis demonstrated that patients who changed drugs were more than twice as likely to discontinue treatment, compared with those who stayed on Lipitor. Reasons for why treatment was discontinued were not available from the database, Pfizer indicated, adding that reasons for switching from one drug to the other were also not available. Furthermore, Pfizer explained that patients in the study were not randomised to each arm, which limits the significance of the findings.

According to lead author Peter Jan Lansberg, many physicians are switching patients to simvastatin because US insurance companies and European governments are under pressure to reduce costs. Lansberg remarked that "it's not beneficial to have a universal switch to cheaper statins. We need to make a distinction between patients who benefit from generic statins and high-risk patients who need a more aggressive therapy."

More ADHD Adherence News

I picked this blip up from, which calls itself "an amazing health tech site". I'll look into it more.

The Food and Drug Administration approved Alliant's Methylin Chewable Tablets and Methylin Oral Solution and the pediatric specialty pharmaceutical company said the goal is to increase compliance.

Dr. Lyndon Waugh of Emory University said children often have difficulty swallowing pills so the new offerings could help ensure they take their medication. It's estimated up to 26 percent of the general population has difficulty swallowing tablets and capsules and the percentage is considered higher for children.

ADHD is a brain disorder that causes children to exhibit inappropriate impulsivity or inattention. It is estimated that 7 percent of school-age children and 4 percent of adults suffer from ADHD, one of the most commonly reported behavioral problems.

My Comment

When I was young (34 now), I had the Flintstone chewable vitamins, as well as the St. Joseph's aspirin, so does this really come as a shock that kids have a difficult time with tablets and pills? Luckily I never suffered from ADHD or any deficit disorders, but hasn't that been the "easy" diagnosis for doctors for many years now? But 7% doesn't seem that high. Maybe I'm confused with ADD?

I know the parameters for diagnosing autism in children have gotten less stringent, raising the diagnosed numbers. But shouldn't ADHD be higher as well?

All I know if that anything pharma does to increase adherence is OK in my book.

Wednesday, September 5, 2007

More Problems with Skin Patches

I found this article on the website - a website I have never heard of until today. I think that the use of patches are fantastic for medication adherence, but as you can see, some have their problems. Written by Katrina Megget.

05/09/2007 - Shire and Noven Pharmaceuticals have announced the voluntary withdrawal of a limited amount of Attention Deficit Hyperactivity Disorder (ADHD) transdermal patches following reports of a mechanical problem when applying the patch.

Up to five per cent of patients reported having trouble removing the release liner from the sticky part of Daytrana (methylphenidate transdermal system) patches, which are used for the treatment of ADHD.

While the mechanics did not affect the release of the drug, Shire decided to take the "proactive step" to withdraw the product. The UK company, which has the global license for Daytrana, said in a statement the patches could continue to be used as long as they were not damaged.

Meanwhile, Noven and Shire, in the first quarter of this year, implemented enhancements to the Daytrana release liner by increasing the release coating on the liner to provide an easier removal.

The improved patches would replace those being withdrawn, which are Daytrana packages with an expiration date of March 31, 2009 or earlier, and Daytrana packages with lot numbers 2563511, 2563611, 2570411.

The withdrawal was not believed to have any affect on either Shire or Noven or on the patches' manufacturing, Shire spokeswoman Jessica Mann told

The withdrawal should cost less than $10m (€7.35m), according to a report by Reuters.

Daytrana, developed and manufactured by Noven, was approved in the US by the FDA last year, and is the first and only transdermal medication approved to treat the symptoms of ADHD. It is approved for children aged six to twelve years with the disorder.

Since its approval, an estimated 700,000 patches have been sold, with last year's sales to Shire totalling $8.6m, with $5.9m recognized in related license revenues.

At the end of July, Shire's net sales of Daytrana exceeded $50m in the 12-months preceding June 30, 2007, triggering a $25m milestone payment to Noven.

The product is based on Noven's proprietary DOT Matrix transdermal technology, which the company claims has significant advantages over standard patch products.

The system uses a patented multiple adhesive mix of silicone, acrylic and the required drug so that the drug is mixed in with the adhesive that holds the patch on the skin. Each patch is a thin, three-layer laminate made up of the patch backing, the drug/adhesive mix and the release liner (the part that gets peeled off and thrown away once the patch is applied).

The patches themselves are compatible with a wide range of medications, and as they deliver the drug more effectively than other competing products they tend to be smaller than other transdermal systems. In addition to this, the patches use one adhesive to hold the drug, and another to make the patch stick to the skin, resulting in superior adhesion to the skin.

The Noven transdermal system is already in use in other products beyond Shire's ADHD patch, including DentiPatch (a transmucosal patch for dental pain), Vivelle-Dot (the world's smallest transdermal estrogen patch), and a number of other hormone therapy patches.

In June, Shire acquired development rights to a new transdermal patch product for ADHD, using amphetamine, after Shire and Noven decided to proceed with clinical development of the patch.

According to Noven, amphetamine products represent about half the US market for stimulant ADHD therapies, and a patch product could bring significant advantages to patients and enhance compliance.