Electronic Access Info to Be Allowed to Patients

For once, the patients are being may be given the rights to see who accesses their electronic medical records. If the current plan stays the course, the earliest you will be able to get a record of who accessed you electronic medical records will not happen until after January 1, 2013. Not that you will be able to do much about it, but at least you will be able to see the when and who accessed your records. This proposed right would allow you to see documentation of the particular person who electronically accessed and viewed your health information.

This will mean that any individual that accesses your electronic health records will be documented for you. This will of course include physicians, hospitals, health plans, and other healthcare organizations, plus law enforcement, judicial hearings, public health investigations. A record is currently kept of this information, but until this rule goes into effect, hopefully on January 1, 2013, you as the patient have no rights to see who accessed your records.

This proposed new privacy rule is issued by the US Department of Health and Human Services and appears in the Federal Register. Public comments are accepted until August 1, 2011. If the rule goes into effect, then all privacy rules must be updated and a new copy of the rules will be given to all patients seen on or after January 1, 2013.

The proposed privacy rule is divided into two separate rights for individuals. The first right sets forth an individual's right to an accounting of disclosures, to include the date of disclosure, what information was disclosed, the recipient of the information, and the purpose of the disclosure – for example, law enforcement. The second right focuses on the right to an access report.

The proposed rule would also would reduce the responding time for an accounting request from 60 days to 30 days and the current six years of disclosures would be reduced to three years.

This proposed rule is an important step in the efforts to promote accountability across the health care system. This would ensure that providers properly safeguard private health information. The need to protect peoples' rights (more appropriately patient's rights) so that they know how their health information has been used or disclosed."

Read the article about this proposed rule change here.

Why Are You Missing Work?

While I had not really thought about it this way, it does answer some questions I was asked by some employers recently, specifically the human resource departments. I attended because the speaker wanted someone with diabetes he could call on. We had prepared for the meeting, but were hit with a few questions that took all of us by surprise. There were four of us on a panel (representing different non-contagious diseases) to answer questions plus the speaker.

This article goes a long way to answer one of the questions and another blogger did a good blog that covered another question. One of the questions was how liberal an employer should be in allowing absences by people with chronic diseases. Most of us had covered absences for doctor visits and other possible related absences. None of us was ready for one question. What about the times when an employee is unable to work a full day, but has no doctor appointment.

We all fumbled with this one. I mentioned depression as one possibility and hypoglycemia as another, but did not realize how much time was being lost. So this survey results article has been sent to the speaker to forward to the employers in attendance.

This survey was recorded from four countries – U.S., UK, Germany, and France and involved 1404 people with Type 1 and Type 2 diabetes that had reported a hypoglycemic event in the preceding month.

The average loss of workplace productivity on a per person, per month basis from a night-time hypoglycemic event was 14.7 missed hours of work or estimated dollar value of $2,294 per person, per year. It is noteworthy that 22.7 percent arrived late or missed a full day and events occurring during work hours showed 18.3 percent needing to leave work early or miss a full day.

Another piece of information also forwarded to the speaker and then to the employers is this from Diabetes Care via a BD Newsletter. This covers work loss and employees leaving work because of disability after age 55. Rather shocking and large numbers.  I had been alerted to this a few days ago by a fellow blogger.

The one recommendation the entire panel agreed should be considered by every employer was having a health screening at least annually for all employees. This would be a preventive measure and could be conducted during the workday and might help catch health issues before they became serious and then with follow-up would encourage people to take the steps to maintain good health. Emphasis was on stopping obesity, hypertension, diabetes, and related health issues.

These studies and the growing numbers of new diabetes every year is creating concern for employers. Some employers are taking positive actions and some are not handling the situation.

Victoza for Type 2, Helps Type 1 As Well

Who would have thought of this? People with Type 1 diabetes taking a medication developed for people with Type 2 diabetes. Apparently it works! While this is a very small study, only 14 adults, the results are surprising. We have had Type 1 people take Metformin and this is well documented (but still off-label use).

The people included in the study had well controlled Type 1, but found that they had even better control with Victoza and lost an average of 10 pounds in six months. They also required less insulin. Those that continued this treatment for a full year continued to see improvement and felt much better overall. This is according to the study leader Paresh Dandona, MD, of the State University of New York. Buffalo.

This was reported at the annual meeting of the Endocrine Society in Boston. Of the 14 adults, all used the insulin pump for their insulin and received Victoza for either one week or 24 weeks. Continuous glucose monitoring showed tight control with insulin, yet all had highs and lows at unusual times.

When Victoza was added to the insulin regimen, the highs and lows were eliminated and after one week the average fasting and blood sugar levels each dropped by approximately 15 percent. Then the added benefits for preprandial insulin decrease of 30 percent and long acting insulin decrease of 32 percent make for further success.

The groups in the 24-week treatment had further decreases in insulin doses and lost an average of 10 pounds. HbA1c levels dropped from 6.5 percent to 6.1 percent. According to Dandona, the patients that have now been treated for up to a year are continuing to have the good effects that they had at the beginning.

Neither Victoza nor Byetta is approved for use in Type 1 diabetes. Dandona says that doctors could prescribe these medications for Type 1 diabetes as “off-label” use, but should only be tried by an endocrinologist specializing in diabetes, and only with careful and frequent monitoring of the patient.

Dandona says the study was done without any drug company support, but that Novo Nordisk is paying for a larger clinical trial. Dandona has asked the National Institutes of Health to support a large-scale study if this larger study yields similar results compared to the pilot study.

Read the report here.

Why Does Everyone Go Crazy Over Small Studies?

This small study (actually two very small studies) seems to have a life of its own. Every year, it seems to be resurrected and trotted out as a larger authority on the issue. In addition, every year, more and more worshipers are encouraged to join the church according to Carol Johnston, PhD from Arizona State University, Department of Nutrition.

Vinegar does aid some people to manage blood glucose levels. Since there is no funds for additional studies, no one knows how long this works and why it does not work for others. Everyone believes the studies as the gospel according to Carol Johnston on vinegar.

Because some people do have some benefits from vinegar, this is constantly brought back annually to introduce it to potential new believers. After a couple of months, the hoopla begins to wane and more people realize that it no longer works for them. So approximately once every year, the believers present it for new converts.

I am no longer a convert as vinegar worked for about two months and then no more. Therefore, I believe that there was something in vinegar that my body needed and once it had been supplied, I received no more benefits. I will not tell you that it won't work for you, but only to not be disappointed if the benefits do not last long. If you get benefits for a longer period, enjoy them.

Do I use vinegar? Yes, on salads and any food that calls for it. I use any variety that works for me and allows me to avoid the sugar-sweetened salad dressings and other foods that are over sweetened with high fructose corn syrup. Other than for a few weeks when I took vinegar by itself to see if the effects worked, once the needs of my body were met, vinegar no longer had any effect on my blood glucose readings.

You can expect to see the push for vinegar about once a year as they try to win new converts, but for those of us that it no longer works for will continue to remind people that what works for one person may not work for others. Yes, if your body needs some of the chemicals found in vinegar, expect to see temporary improvements in blood glucose readings and some people may actually have some long-term improvements.

Read about other articles promoting the use of vinegar here and here. I refer you to my previous blog here. Although most refuse now to put a date on Carol Johnston's studies, at least this one does list two other studies in 2005 and 2006 which were a few years after her studies.

USDA Ditches Food Pyramid for a Healthy Plate?

The United States Department of Agriculture laid an egg on June 2. Color it, slice it, and try to understand it, but it missed the target. Fat is still out which is a mistake and giving whole grains over 25 percent of the plate will do nothing to slow the obesity epidemic in the US.

There are already many articles promoting this "new" distribution. Fortunately there are those who see the weaknesses of this approach. Nothing has improved in the overall scheme of food nutrition. There is no standardization or bringing down the serving sized on food labels or improving the label relationships among the different foods. Many mixed messages still need clarification. The largest problem is that one plate size seems to fit all which anyone with diabetes knows does not work. Individualization is the key for best results.

I know that to lose any weight, I do not need 2000 calories, but this seems to be the message - everyone needs 2000 calories per day. The question of portion sizes, fat intake, and energy expenditures are not figured into the equation. Also too many areas are open to interpretation and misinformation.

The need to stop obesity in adults and children is a worth goal, but the plate icon falls short of setting any real objectives. As for the aah ha moment many have written about, I am afraid this is an ooh no presentation. It is doubtful that the "MyPlate" icon will change Americans' eating lifestyle because it is still dependent on personal responsibility. It can only be hoped that the larger picture will eventually catch the public's attention and interest to learn how to make healthier food choices.

The plate design shows a plate divided into four sections:
     Red is for fruit
     Green is for vegetables
     Orange is for grains
     Purple is for protein, and then add
     Blue as a side dish (or cup) for dairy.

The USDA has improved the portion size from the food pyramid, but a lot is left to be accomplished.

Read the USDA press release here, and a WebMD assessment here. Then take time to read another report here and a report from a nutritional standpoint here. An very interesting blog by Dr. William Davis is here.

There will be many articles and assessments appearing in the months ahead, so be prepared to read both good and bad reports.

Do Your Homework Before Taking Supplements - P2

Now that I have covered manufacturer seals and the lack of significant backing for them, we need to cover the supplements and the cautions put out by the National Institutes of Health.

"Supplement is a broad term that includes vitamins, minerals, herbs and botanicals," says Carol Haggans, a registered dietician and science and health communication consultant for the Office of Dietary Supplements of the National Institutes of Health.
“Herbs and botanicals are derived from plants, while other supplements may include animal sources. Vitamins are essential nutrients made up of organic compounds, while minerals are an imprecise term for certain chemical elements necessary to life, like calcium.”

"They're regulated under the umbrella of foods and are not intended to treat, diagnose, mitigate, cure or prevent disease. If something claims to do that, then it becomes a drug under FDA regulation," Haggans says.

This last statement is where things fall through the cracks of oversight. Too many claims that should bring supplements under FDA regulations go uninvestigated. The manufacturers have learned over time where the line is and don't cross the line. They leave that up to the stores to have leaflets and pamphlets available for customers making these claims. Then if a complaint is filed, they can righteously claim not to have made any such statements.

Haggans adds, "The FDA has instituted 'good manufacturing practices' (GMP) that manufacturers must follow to ensure the identity and quality of supplements and they can take enforcement action if it's unsafe or unfit for human consumption, but they do not routinely test products." Once manufacturers implement these practices, they can display a seal on their packaging, noting their compliance. The problem with this is that the FDA has not issued regulations outlining the GMPs. People think that because congress authorized this, that it must be so.

To be clear about this, the Dietary Supplement Health and Education Act of 1994 (DSHEA) authorized but did not require the FDA to adopt new federal regulations for GMPs for dietary supplements. Under DSHEA, the FDA can issue GMP regulations for dietary supplements that are modeled after food GMPs. To this day, the FDA has not issued any regulations about GMPs.

Like drugs, supplements can combine with other medications in unhealthy ways. "Dietary supplements can interact with both over-the-counter and prescription medication," Haggans says. "That's one reason we tell people to talk with their doctors about all the supplements that they're taking." For example, the anticoagulant medicine warfarin (Coumadin) can interact with gingko biloba and with garlic and cause bleeding. St. John's wort, which is often used to treat depression, can weaken the effects of birth control pills and other medications. Vitamins C and E can also potentially interfere with chemotherapy used to treat cancer.

Doctors might not know about interactions between supplements and prescriptions and since supplement labels don't list warnings, patients need to do their own research: look for guidance from the sites listed in the resource section and talk to a nutritionist or check with reliable sources at "health food" stores or reputable "wellness" centers. This is a situation where watching carefully for side effects is especially important and consumers are mostly on their own to be vigilant.

Some supplements can be monitored by testing blood levels. This can be expensive but it might also reduce problems related to potential toxicity or unusual individual reactions. Check with your doctor to see if blood tests might be suitable for you.

Where can consumers get information? Check with the Office of Dietary Supplements, the National Center for Complementary and Alternative Medicine, and the Memorial Sloan-Kettering Cancer Center. Both keep regularly updated fact sheets on the most commonly used herbs, supplements and vitamins.

Read this article about the supplements.

Do Your Homework Before Taking Supplements - P1

Have you heard of GMP (good manufacturing practices)? Most people have not and for good reason. Congress authorized FDA to set up a plan, but did not make it mandatory. Several organizations that have members among the supplement manufactures set up and submitted some plans to the FDA, but nothing happened. The Federal Drug Administration has done nothing about this, except, yes there is always an exception, occasionally rattling the cage about investigating some supplement here and there.

If you are looking for a reliable manufacturing seal on supplements, forget about it. Those that do exist have no weight of enforcement behind them and are industry developed to say that they have seals of quality for the supplement. The level of quality varies greatly from manufacturer to manufacturer and does not guarantee absolute quality or even that what may be claimed on the product can be depended upon.

I have had health store employees tell me that their products are manufactured under the GMP and have a quality guarantee seal. When I ask who issued the seal, they look at me as if I must have misunderstood their statement and repeat it. When I ask to see the official government seal, they point out the manufacturers seal. I ask if it has been approved by the FDA. Their answer is often yes. Then I ask under which government authorization act was this authorized. Smiles come then and they say The Dietary Supplement Health and Education Act of 1994 (DSHEA). Thinking they had me, they want to know which supplements I wish to purchase.

I then say that I am aware of the act of 1994, but it only authorized FDA to set up regulations, but that the FDA had never set up any regulations. I then say I don't like smoke being blown up my - you know where - and promptly leave the store. One store even had the nerve to call me back to inquire which government agency I worked for. I refused to answer naturally, but did say a full report would be filed. This I did, but to my congressional representative in an email, which I am sure was routed to the delete file.

Over the years, I have only had one store that answered my questions correctly and admitted there was no way to be sure of the quality in every batch from the manufacturer, but that if I felt that something was wrong with any purchase I made they would refund any money upon presentation of the store receipt. I was tempted, but could not bring myself to pay the price asked as it was almost double what I would have paid from any grocery store or warehouse type store.

Do I use any supplements? Yes, I do after I have check out the manufacturer and found few, if any complaints via their local better business bureau and several other agencies. I also look at their internet site for possible claims they make about their products.

There are many conflicting sites of information about supplements and I may not have the best ones, but I looked at approximately 20 sites and chose these.  Site 1, Site 2, Site 3, and Site 4.  Even though several of the sites show seals to be applied to products, none of them have any government enforcement authority to assure quality.

Do You Think the Medication Label is Excessive?

There are many doctors saying that the medication's label leads to information overload. Then why do these doctors want to prescribe medications with many side-effects that may harm their patients? Because, this is what they do and many do not even read about the medications they prescribe. They listen to what the Big Pharma salesperson says and start prescribing.

Then they have patients that start having some of the side-effects listed on the label and know they have problems and just want to believe it is in the patient's head. That is the main reason they want less side-effects listed so they have an easier time convincing their patients that it is all in their heads. This is just my take and the article has not changed my mind.

Yes, the doctors are saying that this information overload is having a negative effect on some people who could benefit from certain prescription medications. The doctors seem rather insistent in their request and want Big Pharma to reduce the number of side-effects listed.

Jon Duke, MD, an assistant professor of medicine at Indiana University School of Medicine in Indianapolis and a researcher at the Regenstrief Institute says he and his colleagues are developing software to help filter, prioritize, and personalize relevant drug safety information. He says he envisions “a dynamic label that uses electronic medical records to pull in the information that is most relevant.”

Unless and until such changes are made, “the key thing is to ask your doctor about side effects because doctors are pretty good filters,” Duke says. “There are some things that most people will never, ever get yet patients are often afraid to take the medicines because of how scary the labels are."

The big question is how well the doctors know the side effects, how they are able to determine which ones are the ones that need concern, and how well do they know their patients. Many doctors fail to take into account the individual patient and how they may be affected by the different side-effects. Certain patients have a greater tendency to be sensitive for certain side-effects while other patients can tolerate the same side-effects. So how does the doctor know?

While this whole thing is directed at the FDA, the side effects may be more that the patients desire if the problems from side effects are not reported until after the patient has problems and ends up in the emergency room or worst yet the morgue. I would rather know about the side effects than having them get the best of me.

Read the article here.