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.